29 Scientific Research & Development jobs in Ireland
Senior Research & Development Engineer I Sustaining & Lifecycle
Galway, Connacht
J&J Family of Companies
Posted 11 days ago
Job Viewed
Job Description
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity?Learn more at Function:**
R&D Product Development
**Job Sub** **Function:**
Biomedical Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Galway, Ireland
**Job Description:**
**Role: Senior Research & Development Engineer I Sustaining & Lifecycle Management**
**Location:** Ballybrit, Galway
**Reports to:** R&D Project Manager
**Live Our Credo & Pursue Our Purpose:**
As part of the Johnson & Johnson family of companies, Our Purpose is 'We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.' We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.
**Diversity, Equity & Inclusion:**
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".
**JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR offers a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
**What is it like to work at JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR Galway?**
+ Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose.
+ We are continuing to better our understanding of clot science through our Neuro Thromboembolic Initiative (NTI). This is a commitment to advance the treatment of stroke through interdisciplinary collaboration and investment in clot and stroke research. How we understand clots and their behaviour enhances our opportunity to design devices that improve patient outcomes and advance the treatment of acute ischemic stroke.
+ Strong new product pipeline and a fast-growing medical device company within J&J.
+ From a People perspective, we invest in our people, and take great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation. This is empowered through our employee resource groups (ERGs) focused on further balances of gender, nationality, capability and more, including the additional attracting of qualified diverse candidates for our open roles.
**Job Summary:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR a Johnson & Johnson company is recruiting for a Senior Research and Development Engineer, Sustaining and Lifecycle Management, in Galway Ireland.
The role of Senior R&D Engineer I supports managing and delivering R&D activities associated with the lifecycle management of the portfolio of products for treatment of acute ischemic stroke with significant technical challenges. Overall responsibility for various aspects of the product's lifecycle including material changes, process improvement, regulatory submissions, shelf-life studies, responding to sales & marketing requests, and returned product investigations.
**The responsibilities and the impact YOU will have:**
+ Acquire an in-depth knowledge of current products from a technical point of view: design, materials, performances, manufacturing process.
+ Product/Process optimization projects - in liaison with Supply Chain and Quality.
+ Support second supplier and/or technical transfer projects.
+ Manage project sub-parts, as part of a larger project team.
+ Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
+ Support regulatory submissions and lead additional Design Verification/Validation studies as required by regional authorities.
+ Lead product Shelf-Life studies through Design Verification testing.
+ Investigations on product complaints and analysis of returned devices
+ Support to CAPA and Non-Conformance process.
+ Evaluation and scoping of process changes, material changes, vendor changes.
+ Support to Labelling changes and implementation.
+ Support to Sales and Marketing for product characterization, competitive testing, field training.
+ Develop and deliver project plans to performance, time and cost targets.
+ Leverage and liaise with external resources, including suppliers, to achieve project goals.
+ Identify and manage of key risks throughout the product lifecycle.
+ Write procedures, protocols, specifications, and reports.
+ Evaluate and assess physician (user) techniques and develop product training materials.
+ Support developing marketing materials (presentations/videos/demos).
+ Other duties as assigned or required.
**We would love to hear from YOU, if you have the following essential requirements:**
+ A minimum of 4 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing) is required.
+ Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments including catheters, stents, delivery systems.
+ Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
+ Data review and statistical methods skills (Minitab).
+ Strong work ethic, creative problem solving, capable of working on own initiative.
+ Excellent writing, presentation, and verbal communication skills essential.
+ Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
+ Excellent interpersonal skills and ability to work with people to achieve results.
+ Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
**Location & Travel**
+ This role will be an onsite role based in Galway, Ireland with flexible work arrangements from time to time in agreement with management and per the J&J Flexible Work policy.
+ As part of a global company, travel may be required from time to time, up to 20%.
**This is what awaits YOU:**
This is an opportunity to work with a ground-breaking biomedical. We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.
Whether you're one of the people who already work here, or you're considering joining the team, we offer:
+ An opportunity to be part of a global market leader.
+ A dynamic and inspiring working environment.
+ Opportunities to work on challenging projects and assignments.
+ Possibilities for further personal and professional development/education.
**Equal Opportunity:**
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
R&D Product Development
**Job Sub** **Function:**
Biomedical Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Galway, Ireland
**Job Description:**
**Role: Senior Research & Development Engineer I Sustaining & Lifecycle Management**
**Location:** Ballybrit, Galway
**Reports to:** R&D Project Manager
**Live Our Credo & Pursue Our Purpose:**
As part of the Johnson & Johnson family of companies, Our Purpose is 'We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.' We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.
**Diversity, Equity & Inclusion:**
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".
**JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR offers a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
**What is it like to work at JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR Galway?**
+ Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose.
+ We are continuing to better our understanding of clot science through our Neuro Thromboembolic Initiative (NTI). This is a commitment to advance the treatment of stroke through interdisciplinary collaboration and investment in clot and stroke research. How we understand clots and their behaviour enhances our opportunity to design devices that improve patient outcomes and advance the treatment of acute ischemic stroke.
+ Strong new product pipeline and a fast-growing medical device company within J&J.
+ From a People perspective, we invest in our people, and take great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation. This is empowered through our employee resource groups (ERGs) focused on further balances of gender, nationality, capability and more, including the additional attracting of qualified diverse candidates for our open roles.
**Job Summary:**
JOHNSON AND JOHNSON MEDTECH, NEUROVASCULAR a Johnson & Johnson company is recruiting for a Senior Research and Development Engineer, Sustaining and Lifecycle Management, in Galway Ireland.
The role of Senior R&D Engineer I supports managing and delivering R&D activities associated with the lifecycle management of the portfolio of products for treatment of acute ischemic stroke with significant technical challenges. Overall responsibility for various aspects of the product's lifecycle including material changes, process improvement, regulatory submissions, shelf-life studies, responding to sales & marketing requests, and returned product investigations.
**The responsibilities and the impact YOU will have:**
+ Acquire an in-depth knowledge of current products from a technical point of view: design, materials, performances, manufacturing process.
+ Product/Process optimization projects - in liaison with Supply Chain and Quality.
+ Support second supplier and/or technical transfer projects.
+ Manage project sub-parts, as part of a larger project team.
+ Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
+ Support regulatory submissions and lead additional Design Verification/Validation studies as required by regional authorities.
+ Lead product Shelf-Life studies through Design Verification testing.
+ Investigations on product complaints and analysis of returned devices
+ Support to CAPA and Non-Conformance process.
+ Evaluation and scoping of process changes, material changes, vendor changes.
+ Support to Labelling changes and implementation.
+ Support to Sales and Marketing for product characterization, competitive testing, field training.
+ Develop and deliver project plans to performance, time and cost targets.
+ Leverage and liaise with external resources, including suppliers, to achieve project goals.
+ Identify and manage of key risks throughout the product lifecycle.
+ Write procedures, protocols, specifications, and reports.
+ Evaluate and assess physician (user) techniques and develop product training materials.
+ Support developing marketing materials (presentations/videos/demos).
+ Other duties as assigned or required.
**We would love to hear from YOU, if you have the following essential requirements:**
+ A minimum of 4 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing) is required.
+ Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments including catheters, stents, delivery systems.
+ Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
+ Data review and statistical methods skills (Minitab).
+ Strong work ethic, creative problem solving, capable of working on own initiative.
+ Excellent writing, presentation, and verbal communication skills essential.
+ Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
+ Excellent interpersonal skills and ability to work with people to achieve results.
+ Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
**Location & Travel**
+ This role will be an onsite role based in Galway, Ireland with flexible work arrangements from time to time in agreement with management and per the J&J Flexible Work policy.
+ As part of a global company, travel may be required from time to time, up to 20%.
**This is what awaits YOU:**
This is an opportunity to work with a ground-breaking biomedical. We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.
Whether you're one of the people who already work here, or you're considering joining the team, we offer:
+ An opportunity to be part of a global market leader.
+ A dynamic and inspiring working environment.
+ Opportunities to work on challenging projects and assignments.
+ Possibilities for further personal and professional development/education.
**Equal Opportunity:**
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
This advertiser has chosen not to accept applicants from your region.
0
Field Quality Assurance (FQA) Specialist (Level 3), Process Excellence
Dublin, Leinster
Amazon
Posted 11 days ago
Job Viewed
Job Description
Description
Operations is the heart and soul of everything Amazon does. As a Field Quality Assurance (FQA) Specialist you will solve complex challenges, partner with the Quality manager and Operations Managers to ensure timely delivery of goods out of the facilities. The individual in this position You will identify, design, and deliver process improvement solutions for various customer experience initiatives, designed to improve Amazon's ability to deliver directly to customers through its network of 3rd party vendors.
Key job responsibilities
Key job responsibilities
- Effectively manage time and complete daily routes. Communicate with assigned dispatcher any problems or concerns on-road that are impacting completion.
- Document feedback and audit results to help identify strengths, as well as areas of improvement
- Use logical thinking, analytical & problem-solving skills
- Navigate using GPS along a route of addresses provided daily; Track specific Geo Codes for addresses using the on-road application.
- Verify potential access codes and delivery instructions for assigned addresses and update records as needed.
- Interact with property managers to provide information from Amazon regarding deliveries; record any provided instructions or feedback
- Interact with property managers as needed to address concerns with service levels being provided.
- Monitor vendor training compliance; analyze and recommend process improvement solutions that positively impact the customer experience.
- Observe deliveries in the field to identify barriers to first-time delivery success; recommend solutions and improvements to Amazon's systems and processes
A day in the life
You will have the exciting opportunity to make history by becoming a member of a Quality Assurance team whose purpose is to solve complex challenges and to create unprecedented customer experiences on a daily basis. We're looking for innovation and problem-solving skills, and a passion to create world class customer experiences that will change the face of commerce.
About the team
Amazon Logistics, or AMZL, handles 'last mile' delivery duties in partnership with third-party distribution businesses. We utilise creative thinking and continuous improvement initiatives to get millions of physical products into the hands of our customers. Our goal is to make our customers' delivery experience as smooth as possible and roll out global delivery solutions for our newest concepts, like Amazon Fresh, Prime Now and Amazon Restaurants.
There are two sides to what we do. Our 'under the roof' associates process millions of products for dispatch to our delivery teams. Our team is people-focused and supportive, particularly as lots of our people work through the night. We focus mostly on operations, with 24/7 shifts in most of our locations.
Meanwhile, our 'on the road' people work with Amazon Flex - a network of delivery contractors. Every year, we continually raise the bar for customer experience with new, innovative delivery services. We look for new ways to overcome industry wide logistics challenges and new ideas to reduce our carbon footprint, supported by a portfolio of cutting-edge vehicles (including Electric Vehicles) and technology to help us do just that.
About the team
Amazon Logistics, or AMZL, handles 'last mile' delivery duties in partnership with third-party distribution businesses. We utilise creative thinking and continuous improvement initiatives to get millions of physical products into the hands of our customers. Our goal is to make our customers' delivery experience as smooth as possible and roll out global delivery solutions for our newest concepts, like Amazon Fresh, Prime Now and Amazon Restaurants.
There are two sides to what we do. Our 'under the roof' associates process millions of products for dispatch to our delivery teams. Our team is people-focused and supportive, particularly as lots of our people work through the night. We focus mostly on operations, with 24/7 shifts in most of our locations.
Meanwhile, our 'on the road' people work with Amazon Flex - a network of delivery contractors. Every year, we continually raise the bar for customer experience with new, innovative delivery services. We look for new ways to overcome industry wide logistics challenges and new ideas to reduce our carbon footprint to help us do just that.
Basic Qualifications
- Advanced proficiency in English language, in both written and verbal communication
- Relevant experience working with data analytics and using these metrics to identify problems
- Relevant experience working with the MS Office suite (Word, Excel, Outlook) in a professional environment
Preferred Qualifications
Preferred qualifications are not required to apply for a position at Amazon. If you have all the basic qualifications above, we'd love to hear from you.
- Customer service skills to effectively communicate with internal and external partners
- Experience using a transportation management - Parcel delivery experience, with market/geographic expertise
Amazon is an equal opportunities employer. We believe passionately that employing a diverse workforce is central to our success. We make recruiting decisions based on your experience and skills. We value your passion to discover, invent, simplify and build. Protecting your privacy and the security of your data is a longstanding top priority for Amazon. Please consult our Privacy Notice ( ) to know more about how we collect, use and transfer the personal data of our candidates.
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.
Operations is the heart and soul of everything Amazon does. As a Field Quality Assurance (FQA) Specialist you will solve complex challenges, partner with the Quality manager and Operations Managers to ensure timely delivery of goods out of the facilities. The individual in this position You will identify, design, and deliver process improvement solutions for various customer experience initiatives, designed to improve Amazon's ability to deliver directly to customers through its network of 3rd party vendors.
Key job responsibilities
Key job responsibilities
- Effectively manage time and complete daily routes. Communicate with assigned dispatcher any problems or concerns on-road that are impacting completion.
- Document feedback and audit results to help identify strengths, as well as areas of improvement
- Use logical thinking, analytical & problem-solving skills
- Navigate using GPS along a route of addresses provided daily; Track specific Geo Codes for addresses using the on-road application.
- Verify potential access codes and delivery instructions for assigned addresses and update records as needed.
- Interact with property managers to provide information from Amazon regarding deliveries; record any provided instructions or feedback
- Interact with property managers as needed to address concerns with service levels being provided.
- Monitor vendor training compliance; analyze and recommend process improvement solutions that positively impact the customer experience.
- Observe deliveries in the field to identify barriers to first-time delivery success; recommend solutions and improvements to Amazon's systems and processes
A day in the life
You will have the exciting opportunity to make history by becoming a member of a Quality Assurance team whose purpose is to solve complex challenges and to create unprecedented customer experiences on a daily basis. We're looking for innovation and problem-solving skills, and a passion to create world class customer experiences that will change the face of commerce.
About the team
Amazon Logistics, or AMZL, handles 'last mile' delivery duties in partnership with third-party distribution businesses. We utilise creative thinking and continuous improvement initiatives to get millions of physical products into the hands of our customers. Our goal is to make our customers' delivery experience as smooth as possible and roll out global delivery solutions for our newest concepts, like Amazon Fresh, Prime Now and Amazon Restaurants.
There are two sides to what we do. Our 'under the roof' associates process millions of products for dispatch to our delivery teams. Our team is people-focused and supportive, particularly as lots of our people work through the night. We focus mostly on operations, with 24/7 shifts in most of our locations.
Meanwhile, our 'on the road' people work with Amazon Flex - a network of delivery contractors. Every year, we continually raise the bar for customer experience with new, innovative delivery services. We look for new ways to overcome industry wide logistics challenges and new ideas to reduce our carbon footprint, supported by a portfolio of cutting-edge vehicles (including Electric Vehicles) and technology to help us do just that.
About the team
Amazon Logistics, or AMZL, handles 'last mile' delivery duties in partnership with third-party distribution businesses. We utilise creative thinking and continuous improvement initiatives to get millions of physical products into the hands of our customers. Our goal is to make our customers' delivery experience as smooth as possible and roll out global delivery solutions for our newest concepts, like Amazon Fresh, Prime Now and Amazon Restaurants.
There are two sides to what we do. Our 'under the roof' associates process millions of products for dispatch to our delivery teams. Our team is people-focused and supportive, particularly as lots of our people work through the night. We focus mostly on operations, with 24/7 shifts in most of our locations.
Meanwhile, our 'on the road' people work with Amazon Flex - a network of delivery contractors. Every year, we continually raise the bar for customer experience with new, innovative delivery services. We look for new ways to overcome industry wide logistics challenges and new ideas to reduce our carbon footprint to help us do just that.
Basic Qualifications
- Advanced proficiency in English language, in both written and verbal communication
- Relevant experience working with data analytics and using these metrics to identify problems
- Relevant experience working with the MS Office suite (Word, Excel, Outlook) in a professional environment
Preferred Qualifications
Preferred qualifications are not required to apply for a position at Amazon. If you have all the basic qualifications above, we'd love to hear from you.
- Customer service skills to effectively communicate with internal and external partners
- Experience using a transportation management - Parcel delivery experience, with market/geographic expertise
Amazon is an equal opportunities employer. We believe passionately that employing a diverse workforce is central to our success. We make recruiting decisions based on your experience and skills. We value your passion to discover, invent, simplify and build. Protecting your privacy and the security of your data is a longstanding top priority for Amazon. Please consult our Privacy Notice ( ) to know more about how we collect, use and transfer the personal data of our candidates.
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.
This advertiser has chosen not to accept applicants from your region.
1
Assoc Research Scientist (Technical Lead) - Biopharma - Athlone, Ireland
Athlone, Leinster
ThermoFisher Scientific
Posted 13 days ago
Job Viewed
Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Assoc Research Scientist - Biopharma**
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
We have a great opportunity for an Associate Research Scientist to join our growing Biopharmaceutical team. This role is a Technical Lead position based at our Analytical GMP facility in Athlone, Ireland.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
**Discover Impactful Work:**
The role of Associate Research Scientist is responsible for the regulatory and scientific conduct of development and stability projects in the Biopharmaceutical Laboratory. Performs troubleshooting across multiple assay formats, clients and cell lines. Calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client.
**A day in the life:**
+ Independently performs analytical testing, method optimization/validation, and/or other speciality technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and completes experiments independently.
+ Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
+ Communicates data and technical issues to clients on a weekly basis (or as needed).
+ Provides technical mentorship and training to staff.
+ Leads analytical (procedural and instrumental) troubleshooting sessions.
+ Assists in preparation and implementation of SOPs and quality systems.
+ Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
**Education and Experience**
+ Degree or equivalent in Chemistry or Biochemistry
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
**Knowledge, Skills, Abilities**
+ Knowledge of general chemistry, biochemistry techniques (Western Blot, total protein by BCA or micro BCA assay, ELISA, HPLC/UPLC)
+ Proven experience of method development of identity and purity assays by Western Blot.
+ Ideally experience in leading CMC studies for biopharmaceutical products including method validation
+ Proficiency on technical operating systems (including Image Lab software)
+ Proven problem solving and troubleshooting abilities
+ Ability to independently perform root cause analysis for method investigations
+ Proven ability in technical writing skills
+ Time management and project management skills
+ Good written and oral communication skills
+ Ability to work in a collaborative work environment with a team
+ Ability to train junior staff
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary and/or standing for typical working hours.
+ Able to lift and move objects up to 25 pounds.
+ Able to work in non-traditional work environments.
+ Able to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**_We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Assoc Research Scientist - Biopharma**
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
We have a great opportunity for an Associate Research Scientist to join our growing Biopharmaceutical team. This role is a Technical Lead position based at our Analytical GMP facility in Athlone, Ireland.
**Location/Division Specific Information**
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
**Discover Impactful Work:**
The role of Associate Research Scientist is responsible for the regulatory and scientific conduct of development and stability projects in the Biopharmaceutical Laboratory. Performs troubleshooting across multiple assay formats, clients and cell lines. Calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client.
**A day in the life:**
+ Independently performs analytical testing, method optimization/validation, and/or other speciality technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and completes experiments independently.
+ Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
+ Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
+ Communicates data and technical issues to clients on a weekly basis (or as needed).
+ Provides technical mentorship and training to staff.
+ Leads analytical (procedural and instrumental) troubleshooting sessions.
+ Assists in preparation and implementation of SOPs and quality systems.
+ Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
**Education and Experience**
+ Degree or equivalent in Chemistry or Biochemistry
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
**Knowledge, Skills, Abilities**
+ Knowledge of general chemistry, biochemistry techniques (Western Blot, total protein by BCA or micro BCA assay, ELISA, HPLC/UPLC)
+ Proven experience of method development of identity and purity assays by Western Blot.
+ Ideally experience in leading CMC studies for biopharmaceutical products including method validation
+ Proficiency on technical operating systems (including Image Lab software)
+ Proven problem solving and troubleshooting abilities
+ Ability to independently perform root cause analysis for method investigations
+ Proven ability in technical writing skills
+ Time management and project management skills
+ Good written and oral communication skills
+ Ability to work in a collaborative work environment with a team
+ Ability to train junior staff
**Work Environment**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary and/or standing for typical working hours.
+ Able to lift and move objects up to 25 pounds.
+ Able to work in non-traditional work environments.
+ Able to use and learn standard office equipment and technology with proficiency.
+ May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1- *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
+ This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**_We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
2
Quality Assurance Specialist 3rd Party Products
PCI Pharma Services
Posted 13 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
3
Quality Assurance Specialist 3rd Party Products
Dundalk, Leinster
PCI Pharma Services
Posted 13 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
4
Quality Assurance Specialist 3rd Party Products
Donore, Leinster
PCI Pharma Services
Posted 13 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
5
Quality Assurance Specialist 3rd Party Products
Blanchardstown, Leinster
PCI Pharma Services
Posted 13 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
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6
Quality Assurance Specialist 3rd Party Products
Dublin, Leinster
PCI Pharma Services
Posted 13 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
+ Part of the Batch File Review Team who:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork closely with QP as issues arise and find resolution
+ Perform a batch file review for batches manufactured/packed at PCI or in third party company.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
+ Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
+ Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
+ Participating customer meetings - discussion/collection/summary about the necessary quality documentation
+ Writing SOPs or Work Instructions
+ Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Degree and/or relevant experience.
+ GMP experience
+ Steriles Experience
+ Good communication skills.
+ Ability to problem solve.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Minimum 2 yrs years' experience working in Quality Assurance
+ Proven track record of showing how results were delivered through management/leadership of others.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
7
Analytical Chemist
Cork, Munster
GE HealthCare
Posted 13 days ago
Job Viewed
Job Description
**Job Description Summary**
As an Analytical Chemist, you will provide expert technical and analytical support to laboratory operations, driving excellence in method development, validation, and troubleshooting. Your role ensures robust analytical performance and regulatory compliance while fostering continuous improvement through data analytics, statistical trending, and data-driven decision-making-making you a key contributor to scientific precision and operational innovation.
**Job Description**
**Key Responsibilities:**
+ Lead analytical method development, validation, and transfer in compliance with ICH guidelines.
+ Act as SME for advanced analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution).
+ Perform statistical analysis and trending of laboratory data (e.g., control charts, capability analysis, stability trends).
+ Develop and maintain dashboards and reports for monitoring QC performance and product quality.
+ Investigate and resolve complex analytical issues (e.g., OOS, OOT, method variability).
+ Actively respond to and troubleshoot performance issues in analytical processes and
+ Procedures.
+ Follow through on specific corrective action items with root causes related to analytical processes and procedures performance.
+ Validation and Qualification: Proactively manage and support the introduction, validation, and qualification of new specifications and methods.
+ Support data integrity initiatives and ensure compliance with ALCOA+ principles.
+ Collaborate with cross-functional teams (QA, Manufacturing, Regulatory) to support product lifecycle management.
+ Review and approve technical documentation including protocols, reports, and SOPs.
+ Train and mentor analysts in both analytical techniques and data analysis tools.
**Qualifications:**
+ BSc, MSc, or PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field.
+ Solid experience in a GMP-regulated pharmaceutical analytical environment.
+ Strong background in analytical method development and validation.
**Skills and Competencies:**
+ Proficiency in chromatographic and spectroscopic techniques.
+ Advanced knowledge of statistical tools and software (e.g., Minitab, JMP, Excel, Python/R for data analysis).
+ Experience with LIMS, Chromeleon and electronic documentation systems.
+ Strong analytical thinking and problem-solving skills.
+ Excellent communication, documentation, and project management abilities.
**Desirable:**
+ Experience in stability studies, cleaning validation, and extractables/leachables.
+ Familiarity with data visualization tools (e.g., Power BI, Tableau).
+ Knowledge of Lean Six Sigma, continuous improvement, and digital transformation in QC labs.
**?** **Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
**Additional Information**
**Relocation Assistance Provided:** No
As an Analytical Chemist, you will provide expert technical and analytical support to laboratory operations, driving excellence in method development, validation, and troubleshooting. Your role ensures robust analytical performance and regulatory compliance while fostering continuous improvement through data analytics, statistical trending, and data-driven decision-making-making you a key contributor to scientific precision and operational innovation.
**Job Description**
**Key Responsibilities:**
+ Lead analytical method development, validation, and transfer in compliance with ICH guidelines.
+ Act as SME for advanced analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution).
+ Perform statistical analysis and trending of laboratory data (e.g., control charts, capability analysis, stability trends).
+ Develop and maintain dashboards and reports for monitoring QC performance and product quality.
+ Investigate and resolve complex analytical issues (e.g., OOS, OOT, method variability).
+ Actively respond to and troubleshoot performance issues in analytical processes and
+ Procedures.
+ Follow through on specific corrective action items with root causes related to analytical processes and procedures performance.
+ Validation and Qualification: Proactively manage and support the introduction, validation, and qualification of new specifications and methods.
+ Support data integrity initiatives and ensure compliance with ALCOA+ principles.
+ Collaborate with cross-functional teams (QA, Manufacturing, Regulatory) to support product lifecycle management.
+ Review and approve technical documentation including protocols, reports, and SOPs.
+ Train and mentor analysts in both analytical techniques and data analysis tools.
**Qualifications:**
+ BSc, MSc, or PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field.
+ Solid experience in a GMP-regulated pharmaceutical analytical environment.
+ Strong background in analytical method development and validation.
**Skills and Competencies:**
+ Proficiency in chromatographic and spectroscopic techniques.
+ Advanced knowledge of statistical tools and software (e.g., Minitab, JMP, Excel, Python/R for data analysis).
+ Experience with LIMS, Chromeleon and electronic documentation systems.
+ Strong analytical thinking and problem-solving skills.
+ Excellent communication, documentation, and project management abilities.
**Desirable:**
+ Experience in stability studies, cleaning validation, and extractables/leachables.
+ Familiarity with data visualization tools (e.g., Power BI, Tableau).
+ Knowledge of Lean Six Sigma, continuous improvement, and digital transformation in QC labs.
**?** **Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
8
Technical Writer
Westport, Connacht
AbbVie
Posted 13 days ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
People. Passion. Possibilities. It's who we are, what we do, and what we stand for.
We are currently recruiting a Technical Writer as part of the overall Product Flow function within the Core 1 Business Unit. In this role, you will be actively involved and manage the batch related CAPA's as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments and QA Lead to ensure thorough investigation is completed and timely resolution and closure is met.
You will assist in the management and closure of existing CAPA's through the evaluation of the current status of corrective and preventive action and co-ordination with relevant personnel to ensure robust actions are in place to prevent reoccurrence prior to closure, lead and support Continuous Improvement initiatives as required to support the overall goals of the Core 1 Process Team. Based on knowledge and previous site experience, you will also be requested to facilitate, support and generate RCA reports.
If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:
Your key responsibilities in this role will be:
+ Maintain strong relationships with management and colleagues in the Core 1 Process Team business unit including operations personnel across all shifts and the QA and Technical team. Articulate the necessary requirements in a clear, concise and persuasive manner.
+ Work with the BU manager on the delivery of the goals and objectives of the team.
+ Manage requirements in order to deliver the KPIs as they relate to the Product Flow function
+ Ensure effective CA and PA are put in place in response to issues arising in the business unit which are raised through the QMS systems including CAPA's / Actions / Effectiveness Checks.
+ Demonstrate active support and involvement in Continuous Improvement initiatives to enhance the Product Flow within the Biologics Business Unit
+ Participate in GEMBA's and Process Confirmations to identify further improvement opportunities within the department
+ Attend daily CAPA / Core 4 Process Team meetings in order to be aware of all tasks assigned to team members and where help and support is required
+ One Vault: Review and approval of assigned documentation as deemed necessary
+ Where necessary co-ordinate RCA sessions in order to resolve issues raised through the CAPA's
+ As requested, compile data to support the KPIs for the team
Qualifications
Education and Experience
You will have:
+ 3rd level qualification and/or 3+ years Pharma or Bio Pharma experience.
+ Understanding of the requirements to work in a regulated GMP industry with knowledge of biologics/pharma operations
+ Access to global Trackwise QMS and understanding of the system is preferred
+ Knowledge of SAP preferred
+ Excellent communication skills
+ Ability to use sound judgment to make effective decisions within appropriate timeframes
+ Proven to be self-directed, self-motivated and ability to prioritise competing priorities
+ Excellent technical writing skills is a requirement for this role and previous experience on GTW i.e. opening RCC's / LIRs / CAPA's is preferrable in order to be successful within this role
+ Ability to generate / update SOP's / Standard Work Instructions
So if all this sounds like the opportunity you have been looking for, apply today!
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
People. Passion. Possibilities. It's who we are, what we do, and what we stand for.
We are currently recruiting a Technical Writer as part of the overall Product Flow function within the Core 1 Business Unit. In this role, you will be actively involved and manage the batch related CAPA's as they arise in the business unit taking them from the initial review state through RCA, approval, batch disposition and delivery of corrective and preventive actions, liaising closely with the relevant Departments and QA Lead to ensure thorough investigation is completed and timely resolution and closure is met.
You will assist in the management and closure of existing CAPA's through the evaluation of the current status of corrective and preventive action and co-ordination with relevant personnel to ensure robust actions are in place to prevent reoccurrence prior to closure, lead and support Continuous Improvement initiatives as required to support the overall goals of the Core 1 Process Team. Based on knowledge and previous site experience, you will also be requested to facilitate, support and generate RCA reports.
If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:
Your key responsibilities in this role will be:
+ Maintain strong relationships with management and colleagues in the Core 1 Process Team business unit including operations personnel across all shifts and the QA and Technical team. Articulate the necessary requirements in a clear, concise and persuasive manner.
+ Work with the BU manager on the delivery of the goals and objectives of the team.
+ Manage requirements in order to deliver the KPIs as they relate to the Product Flow function
+ Ensure effective CA and PA are put in place in response to issues arising in the business unit which are raised through the QMS systems including CAPA's / Actions / Effectiveness Checks.
+ Demonstrate active support and involvement in Continuous Improvement initiatives to enhance the Product Flow within the Biologics Business Unit
+ Participate in GEMBA's and Process Confirmations to identify further improvement opportunities within the department
+ Attend daily CAPA / Core 4 Process Team meetings in order to be aware of all tasks assigned to team members and where help and support is required
+ One Vault: Review and approval of assigned documentation as deemed necessary
+ Where necessary co-ordinate RCA sessions in order to resolve issues raised through the CAPA's
+ As requested, compile data to support the KPIs for the team
Qualifications
Education and Experience
You will have:
+ 3rd level qualification and/or 3+ years Pharma or Bio Pharma experience.
+ Understanding of the requirements to work in a regulated GMP industry with knowledge of biologics/pharma operations
+ Access to global Trackwise QMS and understanding of the system is preferred
+ Knowledge of SAP preferred
+ Excellent communication skills
+ Ability to use sound judgment to make effective decisions within appropriate timeframes
+ Proven to be self-directed, self-motivated and ability to prioritise competing priorities
+ Excellent technical writing skills is a requirement for this role and previous experience on GTW i.e. opening RCC's / LIRs / CAPA's is preferrable in order to be successful within this role
+ Ability to generate / update SOP's / Standard Work Instructions
So if all this sounds like the opportunity you have been looking for, apply today!
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
This advertiser has chosen not to accept applicants from your region.
9