Sr. Validation Engineer - Automation

Amgen; Leinster; On-site; EUR 85,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire seeks a Sr. Validation Engineer to support day-to-day operation of automation systems at the ADL aseptic drug product facility, covering formulation, filling, lyophilisation, inspection and packaging.

The role focuses on maintaining compliance and driving continuous improvement. The successful candidate will manage validation activities, lead deviation investigations, contribute to global compliance initiatives, and collaborate with multi-disciplinary teams to advance Amgen's

Qualifications

• Bachelor’s degree in engineering or life sciences with 5+ years in manufacturing.
• Strong knowledge of GAMP, ANSI/ISA-S88/S95, 21 CFR Part 11, Annex 11.
• Experience with Kneat or similar validation software preferred.
• Ability to manage multiple priorities in a manufacturing environment.

Responsibilities

• Maintain automation systems in a validated state with periodic reviews.
• Lead deviation management including investigation and root-cause analysis.
• Develop and maintain compliance documents and SOPs.
• Collaborate with global teams to drive continuous improvement.
• Support implementation of new technologies for validation maintenance and data analytics.

Skills

Compliance knowledge

Automation knowledge

Communication skills

Team collaboration

Education

Bachelor’s degree in Engineering or Life Science

Tools

Kneat

Job description

Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was among the first to turn new science into safe, effective medicines for patients. Its therapeutics have changed medical practice and helped millions worldwide fight cancer and other serious illnesses. With a broad pipeline of potential new medicines, Amgen remains committed to advancing science to improve lives.

The Sr. Validation Engineer will support the day-to-day operation of automation systems at Amgen Dun Laoghaire (ADL), an aseptic drug product facility specialising in formulation, vial/syringe filling, lyophilisation, inspection and packaging. ADL has a strong culture of continuous improvement and innovation focused on improving health outcomes. Amgen is developing the capability to produce many of its medicines in Dun Laoghaire to support continuity of supply as it expands internationally.

Key Responsibilities

• Help to maintain a safe working environment by following all relevant environmental, health, and safety practices and regulations.
• Manage all processes required to keep automation systems in a validated state, including:
  • Annual security and audit trail reviews
  • Periodic system reviews
  • Preventative maintenance
  • Kneat Super User support
• Own and maintain all Automation compliance documents such as Standard Operating Procedures, Data Integrity Assessments, and Guides.
• Participate in global meetings on compliance topics, influencing the direction of compliance execution and bringing learnings back to the team.
• Lead deviation management for the team, including triage, investigation, root-cause analysis, impact assessment, and follow-up actions to ensure issues are resolved in a compliant and timely manner.
• Champion validation maintenance within the group by leading initiatives that strengthen and streamline execution. Lead team initiatives to introduce new technologies that support validation maintenance, including the use of AI tools and the innovations in data analytics.
• Review execution of compliance tasks by the team to measure and drive continuous improvement.

Preferred Qualifications And Experience

• Experience: At least 5 years’ experience in a compliance or automation role within an operations or manufacturing environment.
• Education: Bachelor’s degree in Engineering, or a life science discipline, with at least 5 years’ experience in an operations or manufacturing environment.
• Compliance knowledge: Working knowledge of the GAMP software development lifecycle, ANSI/ISA-S88 and S95 standards, 21 CFR Part 11, and Annex 11.
• Technical knowledge: Working knowledge of automation and network technologies. Previous experience with Kneat is preferred.
• Work style: Independent, self-motivated, organised, and able to manage multiple priorities in a manufacturing environment.
• Collaboration: Strong team player who embraces a team-based culture and supports effective decision-making through collaboration.
• Communication: Excellent technical writing, communication, and presentation skills.
• Stakeholder management: Proven ability to build relationships, coordinate across departments, and collaborate with teams to achieve shared goals.
• Travel: Availability to travel as needed to support training and vendor visits.