112 Qa Validation Engineer jobs in Ireland
QA Validation Engineer
Sligo, Connacht
AbbVie
Posted 4 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
We are now hiring a QA Validation Engineer on our Ballytivnan Medical Device site in Sligo. In this role, you will join AbbVie's Quality team, supporting the development and maintenance of the site validation program and ensuring compliance with AbbVie, FDA, and cGMP standards. You join a team of experienced validation experts who ensure that our processes and equipment perform to meet the highest standards of product safety, quality, and regulatory compliance across existing products and new products that are being introduced to our site.
Responsibilities:
+ Coordinate, implement, and participate in equipment, process, and software validation activities to maintain regulatory compliance.
+ Develop, execute, and maintain validation master plans, project schedules, protocols, reports, and investigations.
+ Review, approve, and manage quality documents, change control, exception events, and corrective actions.
+ Train team members, support continuous improvement, and ensure cGMP compliance across production areas.
+ Communicate validation activities to peers and management; elevate issues as needed.
Qualifications
+ Bachelor's degree in engineering or a scientific discipline required.
+ Minimum 3 years' validation/QA experience in medical device manufacturing (plastics, moulding, assembly).
+ Solid understanding of cGMP and regulatory requirements.
+ Strong communication, interpersonal, troubleshooting, and organisational skills.
+ Ability to work independently and as part of a team, prioritise tasks, and multitask effectively.
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
We are now hiring a QA Validation Engineer on our Ballytivnan Medical Device site in Sligo. In this role, you will join AbbVie's Quality team, supporting the development and maintenance of the site validation program and ensuring compliance with AbbVie, FDA, and cGMP standards. You join a team of experienced validation experts who ensure that our processes and equipment perform to meet the highest standards of product safety, quality, and regulatory compliance across existing products and new products that are being introduced to our site.
Responsibilities:
+ Coordinate, implement, and participate in equipment, process, and software validation activities to maintain regulatory compliance.
+ Develop, execute, and maintain validation master plans, project schedules, protocols, reports, and investigations.
+ Review, approve, and manage quality documents, change control, exception events, and corrective actions.
+ Train team members, support continuous improvement, and ensure cGMP compliance across production areas.
+ Communicate validation activities to peers and management; elevate issues as needed.
Qualifications
+ Bachelor's degree in engineering or a scientific discipline required.
+ Minimum 3 years' validation/QA experience in medical device manufacturing (plastics, moulding, assembly).
+ Solid understanding of cGMP and regulatory requirements.
+ Strong communication, interpersonal, troubleshooting, and organisational skills.
+ Ability to work independently and as part of a team, prioritise tasks, and multitask effectively.
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.
0
QA Validation Engineer
Sligo, Connacht
Collins McNicholas
Posted today
Job Viewed
Job Description
Our client is seeking a QA Validation Engineer to join their team at their Sligo Facility. Responsibilities To coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities. Coordination / direction and active participation in the validation and quality assurance. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area Essential Requirements Qualification and/or degree in engineering or scientific discipline. Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. Strong communication (written and oral), presentation and troubleshooting skills required Effective interpersonal and organizational skills. Ability to work well both independently and in a team environment. Capable of prioritizing work and multitasking. For a confidential discussion and more information on the role, please contact Emma Daly Skills: moulding and assembly knowledge of automated lines validation
This advertiser has chosen not to accept applicants from your region.
1
QA Validation Engineer
Galway, Connacht
TEAM HORIZON
Posted today
Job Viewed
Job Description
Team Horizon is seeking a QA Validation Engineer on an initial 12-month contract for a Medical Device manufacturer in the Connaught region. Why you should apply: You have experience in Quality / Validation engineering, enjoy a new challenge and have experience working on a range of projects. You enjoy working with a diverse team on interseting projects, and want to work with a globally recognised manufacturing site. Attractive rate on offer with potential for career development. What you will be doing: Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. What you need to apply: Degree in engineering or scientific discipline. 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. Skills: Validation Quality Assurance GMP Regulations GAMP
This advertiser has chosen not to accept applicants from your region.
2
QA Validation Engineer
Sligo, Connacht
Gertek Project Management
Posted today
Job Viewed
Job Description
GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team. The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards. Responsibilities To coordinate the development and maintenance of the site validation program and ensure clien and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities. Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards. Generation/maintenance/execution of the Site Validation Master Plan. Generation/maintenance/execution of Project Validation Plans and schedules. Generation of validation protocols and final reports to cGMP standards. Generation of validation investigations and implementation of corrective actions. Creation/Review/Approval of various quality documents and test data. Management of validation, exception event, and change control processes. Maintenance and tracking of validation equipment, if applicable. Completing all required training before executing a task. Documenting all activities in line with cGMP requirements. Updating of validation procedures, job instructions and batch documentation to reflect current best practices. Performing cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. Coordinating activities to maximize the effectiveness of all of the team members. Maintaining the overall cGMP compliance of the production areas. Communicating with peers and management regarding activities in the area, including elevation of events or concerns. Requirements Qualification and/or degree in engineering or scientific discipline. Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations or similar industry. 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. To start the process click the Continue to Application or Login/Register to apply button below.
This advertiser has chosen not to accept applicants from your region.
3
Qa validation engineer
TEAM HORIZON
Posted today
Job Viewed
Job Description
Team Horizon is seeking a QA Validation Engineer on an initial 12-month contract for a Medical Device manufacturer in the Connaught region.
Why you should apply: You have experience in Quality / Validation engineering, enjoy a new challenge and have experience working on a range of projects.
You enjoy working with a diverse team on interseting projects, and want to work with a globally recognised manufacturing site.
Attractive rate on offer with potential for career development.
What you will be doing: Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European c GMP and GAMP standards.
Generation/maintenance/execution of the Site Validation Master Plan.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
What you need to apply: Degree in engineering or scientific discipline.
3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.
3 years plus of knowledge of c GMP and regulatory requirements relating to the medical device industry.
Skills: Validation Quality Assurance GMP Regulations GAMP
Why you should apply: You have experience in Quality / Validation engineering, enjoy a new challenge and have experience working on a range of projects.
You enjoy working with a diverse team on interseting projects, and want to work with a globally recognised manufacturing site.
Attractive rate on offer with potential for career development.
What you will be doing: Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European c GMP and GAMP standards.
Generation/maintenance/execution of the Site Validation Master Plan.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
What you need to apply: Degree in engineering or scientific discipline.
3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.
3 years plus of knowledge of c GMP and regulatory requirements relating to the medical device industry.
Skills: Validation Quality Assurance GMP Regulations GAMP
This advertiser has chosen not to accept applicants from your region.
4
Qa validation engineer
Sligo, Connacht
Gertek Project Management
Posted today
Job Viewed
Job Description
Ger TEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team.
The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European c GMP and GAMP standards.
Responsibilities To coordinate the development and maintenance of the site validation program and ensure clien and external regulatory, quality, and compliance requirements are met.
Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European c GMP and GAMP standards.
Generation/maintenance/execution of the Site Validation Master Plan.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Requirements Qualification and/or degree in engineering or scientific discipline.
Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations or similar industry.
3 years plus of knowledge of c GMP and regulatory requirements relating to the medical device industry.
To start the process click the Continue to Application or Login/Register to apply button below.
The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European c GMP and GAMP standards.
Responsibilities To coordinate the development and maintenance of the site validation program and ensure clien and external regulatory, quality, and compliance requirements are met.
Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European c GMP and GAMP standards.
Generation/maintenance/execution of the Site Validation Master Plan.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Requirements Qualification and/or degree in engineering or scientific discipline.
Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations or similar industry.
3 years plus of knowledge of c GMP and regulatory requirements relating to the medical device industry.
To start the process click the Continue to Application or Login/Register to apply button below.
This advertiser has chosen not to accept applicants from your region.
5
Qa validation engineer
Sligo, Connacht
Collins McNicholas
Posted today
Job Viewed
Job Description
Our client is seeking a QA Validation Engineer to join their team at their Sligo Facility.
Responsibilities To coordinate the development and maintenance of the site validation program and ensure Abb Vie and external regulatory, quality, and compliance requirements are met.
Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Coordination / direction and active participation in the validation and quality assurance.
Generation/maintenance/execution of the Site Validation Master Plan.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area Essential Requirements Qualification and/or degree in engineering or scientific discipline.
Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.
3 years plus of knowledge of c GMP and regulatory requirements relating to the medical device industry.
Strong communication (written and oral), presentation and troubleshooting skills required Effective interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Capable of prioritizing work and multitasking.
For a confidential discussion and more information on the role, please contact Emma Daly Skills: moulding and assembly knowledge of automated lines validation
Responsibilities To coordinate the development and maintenance of the site validation program and ensure Abb Vie and external regulatory, quality, and compliance requirements are met.
Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Coordination / direction and active participation in the validation and quality assurance.
Generation/maintenance/execution of the Site Validation Master Plan.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area Essential Requirements Qualification and/or degree in engineering or scientific discipline.
Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.
3 years plus of knowledge of c GMP and regulatory requirements relating to the medical device industry.
Strong communication (written and oral), presentation and troubleshooting skills required Effective interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Capable of prioritizing work and multitasking.
For a confidential discussion and more information on the role, please contact Emma Daly Skills: moulding and assembly knowledge of automated lines validation
This advertiser has chosen not to accept applicants from your region.
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6
Validation Engineer
Kilkenny, Leinster
Abbott
Posted 4 days ago
Job Viewed
Job Description
**Have you ever wanted to make a difference?**
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Diabetes Care Kilkenny**
Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
**This is how you can make a difference at Abbott:**
In this role you will be responsible for assisting with the execution of the validation activities for the ADC assembly lines and facility in Kilkenny. You will be responsible for executing on validation activities for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual. There will be a fantastic opportunity to travel with this position to Mainland Europe also.
**You will be responsible for:**
+ Work with R&D. QA, PMO and Global Engineering functions to define and document validation strategies for new product introductions
+ Complete impact assessments of proposed changes and/or new products and determine scope of validation work
+ Generate, execute and/or review validation protocols and associated reports for related Process & Software Validation Activities
+ Identification of improvements to manufacturing process & software and assist with implementation of same
+ Ability to manage multiple responsibilities at once while adhering to project plans and timelines and report on progress to management
+ Provide direction and mentoring to junior engineers as required
+ Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
+ Knowledge of cGMP and industry regulations
**QUALIFICATIONS AND EXPERIENCE**
+ Relevant third level qualification in Engineering/Manufacturing/Science is preferred.
+ Minimum 2 years in the Engineering/Manufacturing/ Scientific field.
+ 2 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
+ Basic understanding of design controls, design transfer and validation lifecycle.
+ Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
Connect with us at or , on LinkedIn at , on Facebook at and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
**Abbott Ireland**
In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
**Diabetes Care Kilkenny**
Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
**This is how you can make a difference at Abbott:**
In this role you will be responsible for assisting with the execution of the validation activities for the ADC assembly lines and facility in Kilkenny. You will be responsible for executing on validation activities for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual. There will be a fantastic opportunity to travel with this position to Mainland Europe also.
**You will be responsible for:**
+ Work with R&D. QA, PMO and Global Engineering functions to define and document validation strategies for new product introductions
+ Complete impact assessments of proposed changes and/or new products and determine scope of validation work
+ Generate, execute and/or review validation protocols and associated reports for related Process & Software Validation Activities
+ Identification of improvements to manufacturing process & software and assist with implementation of same
+ Ability to manage multiple responsibilities at once while adhering to project plans and timelines and report on progress to management
+ Provide direction and mentoring to junior engineers as required
+ Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
+ Knowledge of cGMP and industry regulations
**QUALIFICATIONS AND EXPERIENCE**
+ Relevant third level qualification in Engineering/Manufacturing/Science is preferred.
+ Minimum 2 years in the Engineering/Manufacturing/ Scientific field.
+ 2 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
+ Basic understanding of design controls, design transfer and validation lifecycle.
+ Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
Connect with us at or , on LinkedIn at , on Facebook at and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
7
Validation Engineer
Waterford, Munster
CareerWise Recruitment
Posted today
Job Viewed
Job Description
A Validation Engineer is required by CareerWise Recruitment for our Waterford based pharmaceutical client. If you are experience in aseptic processing, lyophilisation, sterilisation and depyrogenation. This is a 12 month contract. THE ROLE: Designing, executing and reporting on PV/Process Performance Qualifications. Designing, executing and reporting on validation studies for equipment, systems and processes. Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation Maintaining validation documentation through the validation lifecycle Participation in external regulatory inspections and supporting Support Site Change Control process Capable of troubleshooting validation issues associated with projects, process development etc. Maintaining validation documentation through the validation lifecycle REQUIREMENTS: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec Previous validation/product development experience would be highly advantageous for the role. Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations. Knowledge of requirements for of GAMP, ISPE Baseline guides. Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines. Full understanding of relevant quality and compliance regulations Able to execute projects to plan. Good knowledge of quality management systems. Good communication skills at organisation, team and individual levels. Ability to use MS Project and SPC packages an advantage Please call Louise Mulligan today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Validation Engineer aseptic processing lyophilisation
This advertiser has chosen not to accept applicants from your region.
8
Validation Engineer
Cork, Munster
PM Group
Posted today
Job Viewed
Job Description
Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are looking for an experienced Validation Engineer to work on a Client site in Cork. The Validation Engineer will be responsible for the equipment Validation of a technology transfer of existing processes from another site. Responsibilities Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (cleaning, temperature mapping, sterilization). Perform Validation Maintenance program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply. Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements. Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria. Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality to ensure a specific product meets current regulation and quality standards. Prepare, maintain, and review Validation documentation such as CQV documentation for FAT, SAT, IQ, OQ, PQ. Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test. Execute Quality System elements like Change Controls, Deviations and Investigations resulting from equipment and utilities qualification protocol execution. Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems. Qualifications B.S. in Engineering and 3-7 years of experience or related equivalent work experience Must have experience with cGMPs and Good Engineering Practices. Experience in executing multiple projects and participating on cross-functional project teams Knowledge of automation validation preferred Knowledge of Quality control equipment qualification a plus
This advertiser has chosen not to accept applicants from your region.
9