Specialist, Manufacturing

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

Specialist Manufacturing

Overview

Reporting to the Sr Manager Deviations Manufacturing Support, this position will manage the manufacturing deviations for Amgen Dun Laoghaire (ADL).

• 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
• 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 (ie 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 (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment.
• Detailed technical understanding of fill/finish operations.
• 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.
• Flexible and adaptable, with the ability to lead a team through change.