Manufacturing Deviations Lead — Bio/Pharma Investigations

Amgen; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) is seeking a Specialist Manufacturing to manage manufacturing deviations, lead root cause analysis, and develop CAPAs. You will document findings with precision and present to regulators, driving process improvements while coordinating cross-functional teams across the investigation lifecycle.

Strong writing and communication are essential. The role requires a science/engineering degree with extensive biotech/pharma experience and the ability to manage multiple

Qualifications

• Bachelor's degree in Science or Engineering and 5+ years related biotech/pharma experience OR Associate's with 8+ years OR 10+ years in the field.
• Detailed technical understanding of fill/finish operations.
• Experience with compliance, problem-solving, RCAs, project management and quality systems.
• Experience leading complex investigations and cross-functional teams.
• Experience managing multiple priorities in a fast-paced environment.

Responsibilities

• Manage deviation investigations, lead RCAs, develop CAPAs, and document findings.
• Write clear, concise technical documentation of investigations.
• Drive improvements to the investigation process.
• Present investigations to regulators and internal auditors.
• Communicate progress to leadership and impacted areas.
• Coordinate cross-functional teams through complex investigations end-to-end.
• Project-manage investigations from start to finish.
• Present complex topics to groups and convey issues clearly.
• Build relationships across functions and navigate ambiguity.
• Apply inductive and deductive reasoning in investigations.

Skills

Root cause analysis

Project management

Cross-functional collaboration

Technical writing

Quality systems

Communication

Problem solving

Regulatory communication

Education

Bachelor's degree in Science/Engineering

Associate's degree in Science/Engineering

Job description

Amgen Dun Laoghaire (ADL) is seeking a Specialist Manufacturing to manage manufacturing deviations, lead root cause analysis, and develop CAPAs. You will document findings with precision and present to regulators, driving process improvements while coordinating cross-functional teams across the investigation lifecycle.

Strong writing and communication are essential. The role requires a science/engineering degree with extensive biotech/pharma experience and the ability to manage multiple