344 Specialist jobs in Ireland

Lead Mechanical Subject Matter Expert

Clonee, Leinster Meta

Posted 15 days ago

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Job Description

**Summary:**
Meta is seeking a Lead Mechanical Subject Matter Expert (SME) to join our Data Center Facility Operations team. Our data centers serve as the foundation upon which our systems operate to meet the demands of our customers. The Lead Mechanical Subject Matter Expert will be a part of the Facility Operations team and will lead and manage a team of mechanical SMEs who are the data center mechanical system technical operations experts. The candidate will need to have a broad understanding of mechanical system and equipment function and will be responsible for procedure-based mechanical maintenance, troubleshooting, repair, training, and project oversight. The Lead Mechanical Subject Matter Expert will need to be experienced in diverse technologies such as chiller systems, evaporative cooling, DX cooling, water distribution and treatment, emergency diesel generators, and fire suppression systems, and have a working knowledge of building automation systems and electrical distribution. In addition to a good technical capability, this candidate will be equipped with leadership and management skills that will be essential for team alignment to global strategies.
**Required Skills:**
Lead Mechanical Subject Matter Expert Responsibilities:
1. Hire, develop, mentor, and manage an onsite team of mechanical subject matter experts, including performance and HR aspects
2. Ensure appropriate cross-functional collaboration between local mechanical team and applicable local and global teams
3. Serve as an onsite technical/consultative resource on mechanical infrastructure systems and equipment, with emphasis on practical/field application
4. Contribute to mechanical safety program for site
5. Plan, resource, author or approve work packages to cover mechanical troubleshooting, repair, retrofit, and maintenance activities, with an emphasis on assessing & mitigating personnel and system risk
6. Support the full lifecycle of work management responsibilities for mechanical systems including work planning, approval, execution, and closeout
7. Conduct or oversee hands-on troubleshooting, repair, retrofit, and maintenance of mechanical infrastructure systems and equipment
8. Oversee mechanical system configurations and component upgrades to ensure system integrity is maintained and that all modifications to existing systems comply with best practices, including change control processes
9. Provide Quality Assurance/Quality Control (QAQC) oversight of construction projects & maintenance activity
10. Lead and/or participate in root-cause analysis activities in area of expertise, specifically mechanical infrastructure systems and equipment
11. Ongoing monitoring of mechanical systems health, identifying potential issues and implementing corrective actions to prevent equipment failures and ensure continuous operation
12. Provide training to Critical Facility Engineers and other cross functional teams on mechanical equipment, systems, procedures, and changes to include mechanical/fire & life safety/water equipment/systems and procedures
13. Manage vendor relationships for mechanical maintenance and retrofit work
14. Provide feedback on global mechanical maintenance strategies and global mechanical system design improvements
15. Travel expectations: Can be significant during the first 1-3 months for initial training/onboarding and then ongoing occasional travel for factory witness tests, collaboration, etc
**Minimum Qualifications:**
Minimum Qualifications:
16. 8+ years relevant mechanical industry experience or mechanical trade level experience
17. Bachelor's degree in related field plus 3+ years relevant mechanical industry experience will be considered in lieu of 8+ year mechanical industry experience
18. 3+ years in team management
19. Working knowledge of critical facility operations with experience or understanding of procedure-based work
20. Significant experience in comprehending mechanical plans, specifications, and equipment shop drawings
21. Working knowledge of psychrometric charts and refrigeration cycles
22. Working knowledge of electrical, and life safety monitoring and control systems typically used in critical environments
23. Experience interpreting blueprints/CAD drawings
24. Experience working in a highly collaborative, cross-functional environment
25. Proficient with computer systems including documents, spreadsheets, and email
**Preferred Qualifications:**
Preferred Qualifications:
26. Trade Certification or state license in Mechanical (HVAC)
27. Equipment field service engineering experience
28. 7+ years' experience in a data center or other critical environment
29. 7+ years in team management
**Industry:** Internet
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Bulk Bio Subject Matter Expert (SME)

Cork, Munster PM Group

Posted 5 days ago

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Overview The Role We have an exciting opportunity for a Bulk Bio SME to join our team. The role is to work as a Subject Matter Expert providing technical leadership on Bulk Bio. As a member of the global SME Group the person employed can be located in one of the PM Group offices in Ireland, UK, Belgium, The Netherlands or Poland. We work a hybrid work model while the role will require travel to project meetings/workshops as required. Who we are PM Group is an employee owned, international project delivery firm with a team of 3,800+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners. Responsibilities To be a technology leader in nominated area(s) which includes: Being current in technical and subject knowledge Being aware of upcoming technology changes, developments, innovations Writing papers, presenting at industry conferences Being involved with industry bodies such as the ISPE, ICHEME, BioPhorum Promoting knowledge exchange within the company using appropriate forums, COPs, and teams To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and/or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID's and layout philosophies, early phase project reports To technically assist project teams as required To undertake Peer Reviews of work performed by other companies To perform in appropriate SMEs reviews of client sites To engage with global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the company To participate and/or chair technical design reviews as appropriate To actively support and participate in the PM Group's R&D Team (TechTeam) and associated development and innovation activities To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials Travel to Project meetings /workshops as required Other special projects as assigned Specific Knowledge Areas to be covered by the Role include Upstream and downstream unit operations and support functions, as well as familiarity of equipment options available and the selection criteria as to when such options should be chosen. Principles of facility layout such as: Area classifications associated with the required process steps Layout adjacencies Segregation approaches Aspects related to technologies such as: Process closure technologies and approaches Connected and continuous processing Stainless steel and single-use systems Bulk bio automation concepts CIP/SIP Clean utility generation and distribution Waste systems Aspects related to facility operations such as: Operating philosophies GMP Regulatory framework Aspects related to project delivery such as: Basis of design Basis of safety Simulation tools Tech Transfer Commissioning and Qualification Good experience of various modalities and expression systems which may include: Mammalian cells, microbial systems, plant cells, insect cells, blood fractionation, CGT, RNA, Oligonucleotides, Peptides, ADCs, Vaccines Qualifications Bachelor's degree; Masters preferred 15 years+ of appropriate experience in design and/or operations and/or process development A history of wider industry engagement with institutions such as the ISPE and an awareness of key industry technology initiatives and direction Excellent knowledge relating to area of speciality A good understanding of the principles of facility layout and design as appropriate Good appreciation of appropriate Regulatory framework Good presentation skills and be comfortable client interfacing, facilitating workshops and technically assisting project teams. Have the ability to distil down problems to their essence, demonstrate problem solving ability, and have an ability to innovate. Why PM Group? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our 2024 Environmental, Social and Governance Report. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future. PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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Bulk Bio Subject Matter Expert (SME)

Dublin, Leinster PM Group

Posted 5 days ago

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Job Description

Overview The Role We have an exciting opportunity for a Bulk Bio SME to join our team. The role is to work as a Subject Matter Expert providing technical leadership on Bulk Bio. As a member of the global SME Group the person employed can be located in one of the PM Group offices in Ireland, UK, Belgium, The Netherlands or Poland. We work a hybrid work model while the role will require travel to project meetings/workshops as required. Who we are PM Group is an employee owned, international project delivery firm with a team of 3,800+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners. Responsibilities To be a technology leader in nominated area(s) which includes: Being current in technical and subject knowledge Being aware of upcoming technology changes, developments, innovations Writing papers, presenting at industry conferences Being involved with industry bodies such as the ISPE, ICHEME, BioPhorum Promoting knowledge exchange within the company using appropriate forums, COPs, and teams To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and/or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID's and layout philosophies, early phase project reports To technically assist project teams as required. To undertake Peer Reviews of work performed by other companies. To perform in appropriate SMEs reviews of client sites. To engage with global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the company To participate and/or chair technical design reviews as appropriate To actively support and participate in the PM Group's R&D Team (TechTeam) and associated development and innovation activities. To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials. Travel to Project meetings /workshops as required Other special projects as assigned Specific Knowledge Areas to be covered by the Role include Upstream and downstream unit operations and support functions, as well as familiarity of equipment options available and the selection criteria as to when such options should be chosen. Principles of facility layout such as: Area classifications associated with the required process steps Layout adjacencies Segregation approaches Aspects related to technologies such as: Process closure technologies and approaches Connected and continuous processing Stainless steel and single-use systems Bulk bio automation concepts CIP/SIP Clean utility generation and distribution Waste systems Aspects related to facility operations such as: Operating philosophies GMP Regulatory framework Aspects related to project delivery such as: Basis of design Basis of safety Simulation tools Tech Transfer Commissioning and Qualification Good experience of various modalities and expression systems which may include: Mammalian cells, microbial systems, plant cells, insect cells, blood fractionation, CGT, RNA, Oligonucleotides, Peptides, ADCs, Vaccines Qualifications Bachelor's degree; Masters preferred 15 years+ of appropriate experience in design and/or operations and/or process development A history of wider industry engagement with institutions such as the ISPE and an awareness of key industry technology initiatives and direction Excellent knowledge relating to area of speciality A good understanding of the principles of facility layout and design as appropriate Good appreciation of appropriate Regulatory framework Good presentation skills and be comfortable client interfacing, facilitating workshops and technically assisting project teams. Have the ability to distil down problems to their essence, demonstrate problem solving ability, and have an ability to innovate. Why PM Group? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click HERE to read more in our Corporate Responsibility & Health and Safety Report 2023. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future. PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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Subject Matter Expert (SME) - Chemical API

Dublin, Leinster PM Group

Posted 5 days ago

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Job Description

Overview As the Subject Matter Expert (SME) - Chemical API for the Group you can be based from any of our Ireland, UK or Europe offices. Hybrid working in the role which will require travel to project meetings/workshops as required. Who we are PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners. Responsibilities To be a technology leader in nominated area(s) which includes: Being current in technical and subject knowledge Being aware of upcoming technology changes, developments, innovations Writing papers, presenting at industry conferences Being involved with industry bodies such as the ISPE, ICHEME (or equivalents) Promoting knowledge exchange within the company using appropriate forums, COPs, and teams To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and/or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID's and layout philosophies, early phase project reports To technically assist project teams as required. To undertake Peer Reviews of work performed by other companies. To perform in appropriate SMEs reviews of client sites. To engage with global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the company To participate and/or chair technical design reviews as appropriate. To support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements. To actively support and participate in the PM Group's R&D Team (TechTeam) and associated development and innovation activities. To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials. To be 80% bookable. Travel to Project meetings /workshops as required Other special projects as assigned Specific Knowledge Areas to be covered by the Role include Deep knowledge in the processes involved in the development, scale-up and commercial production of Chemical APIs Aspects related to unit operations such as Reactions, Separation Operations, Crystallisation, Gas based reactions. Filtration, Centrifugation, Drying, Milling and blending Principles of facility layout such as: Layout adjacencies Stack-up Segregation approaches Aspects related to technologies such as: Batch, semi-continuous and continuous processing Solvent and reagent handling Materials handling Cleaning technologies Solid, liquid and gaseous waste handling and treatment Automation Utility generation and distribution Aspects related to project delivery such as: Basis of design Safety framework including relief systems, ATEX, and containment Simulation tools Tech Transfer Bid analysis Supplier interfacing Commissioning and Qualification Aspects related to facility operations such as: Operating philosophies GMP Regulatory framework Qualifications Bachelor's degree; Masters preferred Appropriate level of experience around Chemical API facility design and operations A history of wider industry engagement with institutions such as the IChemE, ISPE (or equivalent) and an awareness of key industry technology initiatives and direction Excellent knowledge relating to area of speciality Direct experience working within capital projects and delivery related to process facility design and construction is essential. Good appreciation of appropriate Regulatory framework, such as FDA, EMA, ICH Guidelines Find out more about PM Group and our projects. Why PM Group? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Please visit our website to read more in our Corporate Responsibility & Health and Safety Report 2020. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future. PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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Logistics Specialist, Logistics Specialist

Dublin, Leinster Amazon

Posted 6 days ago

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Description
Amazon offers an exciting opportunity to join a creative, dynamic team of Logistics Specialists, dedicated to providing our Customers with a world class Customer Service. Be a part of operating the world's largest cloud computing infrastructure. Amazon Web Services is seeking bright, motivated and hardworking individuals to fill Logistics Specialist position. The ideal candidate possesses a strong work ethic, attention to detail, the ability to meet deadlines, and a commitment to Safety & Operational Excellence.
Logistics Specialists monitor inventory levels to ensure that proper stock levels are maintained to support build and repair activities. They receive parts, maintain inventory, and check-out parts as needed to Data Center Technicians and Engineers. They will also be responsible for loading and unloading shipments and transporting parts between different locations. This position involves frequent lifting of materials and products. Logistics Specialists will be required to keep precise records of all commodities going in and out of company. They also maintain the cleanliness, organization, and safety of all workspaces. They must be available to work shift work.
The ideal candidate will have experience working in a warehouse or distribution environment, as well as experience and knowledge of reverse logistics processes. Experience handling vendor relationships is helpful.
Key job responsibilities
- Requires standing, sitting, and walking for prolonged periods of time?
- Typically work is in a warehouse environment where the noise level is moderate to loud?
- May also work is in a data center environment where the noise level is loud?
- Occasionally assist in loading and unloading shipments?
- Occasionally exposed to extreme cold or hot weather
Work Environment
- Work with and/or around moving mechanical parts
- Noise level varies and can be loud
- Temperature between 60 and 90 degrees, and will occasionally exceed 90 degrees
A day in the life
About AWS
Diverse Experiences
AWS values diverse experiences. Even if you do not meet all of the preferred qualifications and skills listed in the job description, we encourage candidates to apply. If your career is just starting, hasn't followed a traditional path, or includes alternative experiences, don't let it stop you from applying.
Why AWS?
Amazon Web Services (AWS) is the world's most comprehensive and broadly adopted cloud platform. We pioneered cloud computing and never stopped innovating - that's why customers from the most successful startups to Global 500 companies trust our robust suite of products and services to power their businesses.
Inclusive Team Culture
Here at AWS, it's in our nature to learn and be curious. Our employee-led affinity groups foster a culture of inclusion that empower us to be proud of our differences. Ongoing events and learning experiences, including our Conversations on Race and Ethnicity (CORE) and AmazeCon (gender diversity) conferences, inspire us to never stop embracing our uniqueness.
Mentorship & Career Growth
We're continuously raising our performance bar as we strive to become Earth's Best Employer. That's why you'll find endless knowledge-sharing, mentorship and other career-advancing resources here to help you develop into a better-rounded professional.
Work/Life Balance
We value work-life harmony. Achieving success at work should never come at the expense of sacrifices at home, which is why we strive for flexibility as part of our working culture. When we feel supported in the workplace and at home, there's nothing we can't achieve in the cloud.
About the team
AWS Infrastructure Services (AIS)
AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we're the people who keep the cloud running. We support all AWS data centers and all of the servers, storage, networking, power, and cooling equipment that ensure our customers have continual access to the innovation they rely on. We work on the most challenging problems, with thousands of variables impacting the supply chain - and we're looking for talented people who want to help.
You'll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You'll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you'll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion.
Basic Qualifications
- Leaving certificate or equivalent
- Experienced in inventory control and inventory management systems
- Effective listening and communication (verbal and written)
Preferred Qualifications
- Experience in inventory and distribution warehousing practices and proficient with computers and Microsoft office (Outlook, Word, Excel)
- Knowledge of Inventory Management tools
- Experience in lean operational practices
- Full clean driver's license and/or Reach truck license
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.
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QA Specialist

N37 A Jazz Pharmaceuticals

Posted today

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Job Description

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.

Essential Functions/Responsibilities

  • Implement and oversee the quality systems ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
  • Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
  • Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
  • Generate QMS Standard Operating Procedures (SOPs) to reflect these processes, which are easy to follow and promote both compliance and efficient operations, in accordance with facility requirements.
  • Review and approve procedures, documents and records (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
  • Review and approve technical support documentation. (Examples include cleaning, process, method validation).
  • Generate and approve Quality documents (e.g. Annual Product Reviews, Licence variations etc.).
  • Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA.
  • Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality impact of changes.
  • Support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required.
  • Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
  • Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
  • Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients.
  • Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with agreed timelines.
  • Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging.
  • Assist in preparation and presentation of GMP training programmes.
  • Participate in initiatives and action plans for the development of QA and improvement of GMP compliance.
  • Involved in site-wide projects and continuous improvement processes.

Required Knowledge, Skills, and Abilities

  • 3-7 years experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
  • Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
  • Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority.
  • Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a ‘go-to’ expert across the business in area of expertise.
  • Recognize areas for improvement and use initiative to implement change programs in support of progress.
  • Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
  • Ability to generate documentation which is of a high standard.
  • Possess good organizational skills and attention to detail.
  • Possess good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines.
  • Demonstrated expertise in the area of Data Integrity highly desirable.
  • Experience in participation in regulatory audits (HPRA or FDA) desirable.
  • Computer skills i.e., Microsoft Office, Windows etc. Experience in Reliance, LIMS & SAP would be advantage.

Required/Preferred Education and Licenses

  • BSc in science discipline required.
  • Lead auditor certification highly desirable

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
This advertiser has chosen not to accept applicants from your region.

QA Specialist

N37 A Jazz Pharmaceuticals

Posted 1 day ago

Job Viewed

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Job Description

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.

Essential Functions/Responsibilities

  • Implement and oversee the quality systems ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
  • Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
  • Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
  • Generate QMS Standard Operating Procedures (SOPs) to reflect these processes, which are easy to follow and promote both compliance and efficient operations, in accordance with facility requirements.
  • Review and approve procedures, documents and records (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
  • Review and approve technical support documentation. (Examples include cleaning, process, method validation).
  • Generate and approve Quality documents (e.g. Annual Product Reviews, Licence variations etc.).
  • Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA.
  • Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality impact of changes.
  • Support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required.
  • Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
  • Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
  • Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients.
  • Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with agreed timelines.
  • Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging.
  • Assist in preparation and presentation of GMP training programmes.
  • Participate in initiatives and action plans for the development of QA and improvement of GMP compliance.
  • Involved in site-wide projects and continuous improvement processes.

Required Knowledge, Skills, and Abilities

  • 3-7 years experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
  • Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
  • Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority.
  • Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a ‘go-to’ expert across the business in area of expertise.
  • Recognize areas for improvement and use initiative to implement change programs in support of progress.
  • Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
  • Ability to generate documentation which is of a high standard.
  • Possess good organizational skills and attention to detail.
  • Possess good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
  • Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines.
  • Demonstrated expertise in the area of Data Integrity highly desirable.
  • Experience in participation in regulatory audits (HPRA or FDA) desirable.
  • Computer skills i.e., Microsoft Office, Windows etc. Experience in Reliance, LIMS & SAP would be advantage.

Required/Preferred Education and Licenses

  • BSc in science discipline required.
  • Lead auditor certification highly desirable

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
This advertiser has chosen not to accept applicants from your region.
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EHS Specialist

Bray, Leinster CommScope, Inc.

Posted 9 days ago

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Job Description

EHS Specialist
Req ID: 79200
Location:
Bray, Dublin, Ireland
In our 'always on' world, we believe it's essential to have a genuine connection with the work you do.
CommScope's Environment and Health & Safety (EHS) strategy is an integral part of the company's overall strategy. This position will be responsible to ensure CommScope fulfils the global EHS goals and objectives at our facilities in **Bray, Ireland.**
You will be responsible for ensuring the effectiveness of the CommScope Global EHS Knowledge Management System, Entropy, ensuring information accuracy and timely reporting. The EHS Officer will play a meaningful role in ensuring compliance with health and safety standards, promoting a safe work environment, and leading all aspects of environmental health and safety across projects.
**How You'll Help Us Connect the World:**
The responsibilities for this role involve working closely with senior management to promote a positive health and safety culture throughout the company. The position requires becoming the Super User for the CommScope Entropy system and acting as the main point of contact between NSAI and all relevant departments and individuals at CommScope regarding the system.
Key duties include coordinating system upgrades, providing one-on-one training, and resolving any issues that arise. Additionally, the role involves crafting mentorship materials and coordinating tutor-led training when necessary, along with offering general support for users and sites applying the Entropy system.
Managing the EHS Global standards and corporate guidance documents within the system is essential. Supervising monthly KPI records is also a key task, ensuring their accuracy and timely reporting. The role involves being responsible for the implementation and adoption of the Entropy system at various sites, addressing any deficiencies by advising the Regional EHS Manager or taking appropriate action.
Generating EHS reports from the system as needed is part of the job. The role also supports initiatives to manage and reduce environmental risks and liabilities while working to improve the company's overall EHS performance and external reputation.
**Required Qualifications for Consideration:**
+ 3 to 5 years of EH&S experience in Ireland.
+ Knowledge of statistics, data collection, analysis, and data presentation.
+ EH&S qualifications mandatory
**You Will Excite Us If You Have:**
+ Degree or diploma in Occupational Health and Safety or an Associate's degree/EHS qualification preferred.
+ Instructor certifications (e.g., Manual Handling, Working at Height) are advantageous but not essential.
We offer private medical insurance, life assurance, contribution Pension Scheme, Cycle to Work Scheme, recognition programme, contribution towards Sports Club Membership, Subsided Canteen and Free Parking.
What Happens After You Apply: Learn how to prepare yourself for the next steps in our hiring process by visiting CommScope?**
CommScope is on a quest to deliver connectivity that empowers how we live, work, and learn. Our employees push the boundaries of communications technology that enables groundbreaking discoveries like 5G, the Internet of Things, and gigabit speeds for everyone, everywhere. With our unmatched expertise in copper, fiber, and wireless infrastructure, our global clients rely on us to outperform today and be ready for the needs of tomorrow.
If you want to grow your career alongside forward-thinking, hardworking, and caring people who strive to create what's next.come connect to your future at CommScope.
CommScope is an Equal Opportunity Employer (EEO), including people with disabilities and veterans. If you are seeking an accommodation for the application or interview process, please contact us to submit your request at
**Learn more about how we're on a quest to connect the future and build what's next.**
**Job Segment:** Telecommunications, Telecom, Network, Technology
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Specialist, Documentation

Sligo, Connacht AbbVie

Posted 11 days ago

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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
Job Description
AbbVie Manorhamilton Road are looking for a Documentation Specialist to join their team on a 6 month contract. You will be coordinating the development and the maintenance of the AbbVie Laboratory Document Control system in compliance with all applicable company and regulatory requirements.
What you will do:
+ Manage the document management system to ensure compliance with Quality requirements and Regulations.
+ Be responsible for the company Documentation issuance, control and retention ensuring compliance with all policies and procedures.
+ Work closely with the global doc centre and site stakeholders in processing, reviewing and approval process of document change requests
+ Assist with external audits and inspections through coordination, participation and compilation of document packages for audit.
+ Comply with the EHS policy & procedures and demonstrate EHS best practices at all times.
Qualifications
What you will need:
+ 3rd level qualification in a relevant discipline
+ Minimum 2 years in a similar role
+ Previous experience in a GMP environment (pharma would be an advantage)
+ Excellent computer skills, MS office skills essential
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:
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Training Specialist

Kilkenny, Leinster Abbott

Posted 12 days ago

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Job Description

**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Abbott in Ireland**
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
**Abbott Diabetes Care Kilkenny**
Abbott Diabetes Care has opened a new site, in Kilkenny, that is at the forefront of Diabetes care with the latest technology, to manufacture FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.
**MAIN PURPOSE OF ROLE**
The main responsibility of the Training Coordinator is to monitor and complete site training queries, ensuring delivery of safe and effective products that meet customer needs whilst maintaining compliance.
**MAIN RESPONSIBILITIES**
- Monitoring and answering the training queries submitted via the training request system and mailbox.
- Entering new hires/employees into the training system in a timely manner and ensuring the correct training plan is assigned.
- Running reports to ensure the training system is in a constant state of compliance.
- Ensuring compliance with policies and procedures.
- Provision of assistance to various functions on the correct selection of training plans and training materials.
- Perform Quality review of training documentation in accordance with approved procedures to ensure compliance with Good Documentation Practices.
**_QUALIFICATIONS AND EXPERIENCE_**
- Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
- Minimum 2+ years previous experience in medical / pharmaceutical industry would be preferred.
- Experience with LMS platforms and e-learning tools.
- Strong communication, facilitation, and interpersonal skills.
- Problem-solving and adaptability in dynamic environments.
**What we Offer:**
Attractive compensation package that includes competitive pay, as well as benefits such as
+ Family health insurance
+ Excellent pension scheme
+ Life assurance
+ Career Development
+ Fantastic new facility
+ Growing business plus access to many more benefits.
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
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