About this role
Career Category Compliance 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
.Salary Range 60,090.75 EUR - 81,299.25 EUR