Senior Facilities & Engineering Compliance Lead

Amgen; Leinster; On-site; EUR 70,000 - 95,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) seeks a Senior Associate with Facilities & Eng Compliance to lead investigations for deviations in fill/finish and packaging, ensuring GMP compliance and regulatory readiness.

The role includes coordinating cross-functional teams, presenting findings to inspectors and auditors, and driving continuous improvements in the investigation process in a day-role setting.

Qualifications

• Bachelor's degree and 5+ years directly related biotech/pharma experience.
• Associate's degree with 8+ years directly related experience; or 10+ years in biotech/pharma manufacturing environment.
• Detailed technical understanding of fill/finish operations.
• GMP and regulatory knowledge (FDA, EU GMP, Annex 1).
• Experience with compliance, problem-solving, root cause analysis, project management, and quality systems.
• Experience leading complex investigations and cross-functional teams.
• Excellent technical writing.

Responsibilities

• Lead investigations for deviations in fill/finish/inspection and packaging.
• Establish investigation teams, conduct root cause analyses, develop CAPAs and product impact assessments.
• Produce compliant documentation of findings; clear, concise writing of complex investigations.
• Drive improvements to the investigation process and present findings to regulators and internal auditors.
• Coordinate cross-functional teams and manage investigations end-to-end; ensure schedule adherence.

Skills

Technical writing

Root cause analysis

Project management

Quality systems

Regulatory knowledge (FDA, EU GMP, Ann

Education

Bachelor's Degree in Science or Engineering

Associate's Degree in Science or Engineering

Job description

Amgen Dun Laoghaire (ADL) seeks a Senior Associate with Facilities & Eng Compliance to lead investigations for deviations in fill/finish and packaging, ensuring GMP compliance and regulatory readiness.

The role includes coordinating cross-functional teams, presenting findings to inspectors and auditors, and driving continuous improvements in the investigation process in a day-role setting.