Lead Automation Validation & Compliance Engineer

Amgen; Dublin; On-site; EUR 77,000 - 104,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) seeks a Sr. Validation Engineer to support the day-to-day operation of aseptic automation systems.

You will ensure validation, compliance, and documentation quality within a facility expanding to support global supply, with emphasis on continuous improvement and data analytics. Ideal candidates bring 5+ years in compliance or automation in manufacturing, a engineering/life sciences degree, and knowledge of GAMP, 21 CFR Part 11, and related standards.

Qualifications

• Education: Bachelor’s degree in Engineering or life sciences with at least 5 years in operations or manufacturing.

Responsibilities

• Maintain automation systems in a validated state, including annual reviews and preventative maintenance.
• Lead deviation management with triage, investigation, and root-cause analysis.
• Own and maintain compliance documents like SOPs, data integrity, and guides.
• Collaborate across teams and participate in global compliance discussions to drive improvements.

Skills

Compliance

Automation

Documentation

Stakeholder management

Communication

Travel

Education

Bachelor's degree in Engineering or life sciences

Tools

Kneat

GAMP

ISA-S88

ISA-S95

21 CFR Part 11

Annex 11

Job description

Amgen Dun Laoghaire (ADL) seeks a Sr. Validation Engineer to support the day-to-day operation of aseptic automation systems.

You will ensure validation, compliance, and documentation quality within a facility expanding to support global supply, with emphasis on continuous improvement and data analytics. Ideal candidates bring 5+ years in compliance or automation in manufacturing, a engineering/life sciences degree, and knowledge of GAMP, 21 CFR Part 11, and related standards.