Senior Associate, Facilities & Engineering Compliance

Amgen Inc. (IR); Ireland; Remote; EUR 60,000 - 81,000; Full time

Job summary

Amgen Dun Laoghaire in Ireland seeks L4 Senior Associate Validation (Facilities & Eng Compliance) to manage deviations in fill/finish and packaging, lead investigations, establish teams, and ensure GMP compliance.

You will drive root-cause analyses, develop CAPAs, prepare product impact assessments, and present findings to regulators and internal audits, maintaining audit-ready documentation and cross-functional collaboration.

Qualifications

• Bachelor's Degree in Science or Engineering with 5+ years of related biotech/pharma manufacturing experience.
• Associate's Degree in Science or Engineering with 8+ years related experience.
• 10+ years directly related experience in biotech/pharma manufacturing.
• GMP and regulatory knowledge (FDA, EU GMP, Annex 1).
• Experience leading complex investigations and cross-functional teams.
• Excellent technical writing and communication skills.

Responsibilities

• Manage deviation investigations and establish investigation teams.
• Lead root cause analysis and develop CAPAs.
• Prepare product impact assessments and compliant documentation.
• Communicate investigation progress to stakeholders and leadership.
• Support inspection readiness and regulatory commitments.
• Coordinate cross-functional investigations and ensure on-schedule delivery.
• Present investigations to regulatory inspectors and internal audits.
• Maintain audit-ready validation documentation.

Skills

GMP knowledge

Root cause analysis

Regulatory inspections

Project management

Cross-functional teamwork

Technical writing

Quality systems

Education

Bachelor's Degree in Science or Engineering

Associate's Degree in Science or Engineering

10+ years biotech/pharma manufacturing experience

Job description

Amgen Dun Laoghaire in Ireland seeks L4 Senior Associate Validation (Facilities & Eng Compliance) to manage deviations in fill/finish and packaging, lead investigations, establish teams, and ensure GMP compliance.

You will drive root-cause analyses, develop CAPAs, prepare product impact assessments, and present findings to regulators and internal audits, maintaining audit-ready documentation and cross-functional collaboration.