Senior Associate Facilities & Engineering Compliance

**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