Sr. Associate Facilities & Engineering Compliance (Day role)

 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