Senior Facilities & Engineering Compliance Lead

Biopharma Careers; Dún Laoghaire; On-site; EUR 60,000 - 81,000; Full time

Job summary

Amgen Dun Laoghaire is seeking an L4 Senior Associate for Facilities & Eng Compliance to manage deviations and ensure GMP regulatory adherence. The role emphasizes leading investigations for fill/finish and packaging, with strong emphasis on technical writing and cross-functional collaboration.

This is a day role based in Dun Laoghaire, Ireland. Candidates should have 5+ years in biotech/pharma manufacturing or related fields, with detailed QA, regulatory, and project management experience.

Qualifications

• GMP knowledge
• Regulatory knowledge (FDA, EU GMP)
• Root cause analysis
• Investigation leadership
• Project management
• Quality systems
• Technical writing
• Cross-functional collaboration
• Process improvement
• Analytical/problem solving

Responsibilities

• Manage deviation investigations with root cause analysis and CAPA development.
• Prepare regulatory-compliant investigation documentation.
• Lead cross-functional teams through investigations and end-to-end project management.
• Present investigations to regulators and internal auditors.
• Ensure GMP compliance and inspection readiness.

Education

Bachelor's Degree in Science or Engineering

Associate's Degree in Science or Engineering

Job description

Amgen Dun Laoghaire is seeking an L4 Senior Associate for Facilities & Eng Compliance to manage deviations and ensure GMP regulatory adherence. The role emphasizes leading investigations for fill/finish and packaging, with strong emphasis on technical writing and cross-functional collaboration.

This is a day role based in Dun Laoghaire, Ireland. Candidates should have 5+ years in biotech/pharma manufacturing or related fields, with detailed QA, regulatory, and project management experience.