Sr. Associate Facilities & Engineering Compliance (Day role)

Biopharma Careers; Dún Laoghaire; Sur place; EUR 60 000 - 81 000; Plein temps

Résumé du poste

Amgen Dun Laoghaire is seeking an L4 Senior Associate for Facilities & Eng Compliance to manage deviations and ensure GMP regulatory adherence. The role emphasizes leading investigations for fill/finish and packaging, with strong emphasis on technical writing and cross-functional collaboration.

This is a day role based in Dun Laoghaire, Ireland. Candidates should have 5+ years in biotech/pharma manufacturing or related fields, with detailed QA, regulatory, and project management experience.

Qualifications

• GMP knowledge
• Regulatory knowledge (FDA, EU GMP)
• Root cause analysis
• Investigation leadership
• Project management
• Quality systems
• Technical writing
• Cross-functional collaboration
• Process improvement
• Analytical/problem solving

Responsabilités

• Manage deviation investigations with root cause analysis and CAPA development.
• Prepare regulatory-compliant investigation documentation.
• Lead cross-functional teams through investigations and end-to-end project management.
• Present investigations to regulators and internal auditors.
• Ensure GMP compliance and inspection readiness.

Formation

Bachelor's Degree in Science or Engineering

Associate's Degree in Science or Engineering

Description du poste

Career Category

Compliance

Job Description

L4 Senior Sr Associate Facilities & Eng Compliance

Overview: Reporting to Validation Management, this position will manage Facilities & Eng 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 60,090.75EUR-81,299.25EUR