Sr. Associate Facilities & Engineering Compliance (Day role)
$60,090–$81,299 year
On-siteDún Laoghaire, Leinster, Ireland
Job Summary
Lead investigations for fill/finish, inspection, and packaging deviations by establishing teams, driving root cause analysis, developing CAPAs, and completing product impact assessments. Manage end-to-end project execution for complex investigations while ensuring GMP and regulatory compliance across all documentation. Present findings to regulatory inspectors and internal auditors, clearly communicate progress to impacted areas, and drive continuous improvements to the investigation process. Coordinate cross-functional teams to maintain audit-ready validation documentation and navigate ambiguity with structured problem-solving.
Required Qualifications
- Bachelor's Degree in Science or Engineering
- 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. process development, engineering, quality)
- 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
- 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
- Day role availability
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