Sr. Associate Facilities & Engineering Compliance (Day role)

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

L4 Senior Sr Associate Facilities & Eng Compliance

Overview: Reporting to Validation Management, this position will manage Facilities & Engineering Deviations and Compliance for Amgen Dun Laoghaire (ADL).

This L4 Senior Associate Validation (Facilities & Eng Compliance) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations and ensuring compliance with GMP and regulatory expectations. Please note this is a day role.

This role will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:

Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing compliant documentation of all findings.

• Clear and concise technical writing of complex investigations
• Drive improvements to the investigation process
• Present investigations to regulatory inspectors and internal auditors
• Clearly communicate investigation progress to impacted areas and leadership

Quality Systems & Compliance

• Ensure compliance with GMP regulations, company procedures, and quality standards.
• Support inspection readiness and regulatory commitments.
• Validation lifecycle compliance
• Ensuring validation documentation remains audit-ready and GMP compliant.

Coordinate and lead cross-functional teams through complex investigations, and complete tasks on schedule.

• Project management of the investigations end to end
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Able to apply inductive and deductive reasoning in the investigation process

Qualifications

• Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. process development, engineering, quality)

OR

• Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. process development, engineering, quality)
• 10+ years directly related experience in a biotech/pharma manufacturing or 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, critical thinking, project management, and quality systems.
• Experience leading complex investigations.
• Experience participating in and leading cross-functional teams.
• Experience in managing multiple, competing priorities in a fast-paced environment.
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Excellent technical writing.

Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff.

• Ability to be flexible and manage change.

Personal Attributes

• Detail-oriented with a strong focus on quality and compliance.
• Ability to work under pressure and manage multiple priorities effectively.
• Proactive and self-motivated with a continuous improvement mindset