Senior Automation Validation Engineer — Life Sciences

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 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