Sr. Associate Facilities & Engineering Compliance (Day role)

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:

Bachelors 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

* Associates 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