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.
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Clear and concise technical writing of complex investigations
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Drive improvements to the investigation process
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Present investigations to regulatory inspectors and internal auditors
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Clearly communicate investigation progress to impacted areas and leadership
Quality Systems & Compliance
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Ensure compliance with GMP regulations, company procedures, and quality standards.
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Support inspection readiness and regulatory commitments.
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Validation lifecycle compliance
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Ensuring validation documentation remains audit-ready and GMP compliant.
Coordinate and lead cross-functional teams through complex investigations, and complete
tasks on schedule.
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Project management of the investigations end to end
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Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
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Build effective relationships across functions.
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Navigate through ambiguity and provide a structured problem-solving approach.
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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.
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Detailed technical understanding of fill/finish operations.
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GMP and regulatory knowledge (FDA, EU GMP, Annex 1)
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Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
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Experience leading complex investigations.
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Experience participating in and leading cross-functional teams.
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Experience in managing multiple, competing priorities in a fast-paced environment.
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Experience presenting to inspectors during regulatory inspections and internal audits.
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Excellent technical writing.
Excellent presentation and communication skills, ability to communicate and collaborate
with technical and management staff.
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Ability to be flexible and manage change.
Personal Attributes
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Detail-oriented with a strong focus on quality and compliance.
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Ability to work under pressure and manage multiple priorities effectively.
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Proactive and self-motivated with a continuous improvement mindset
