Senior Process Development Engineer (NPI & Tech Transfer)

Amgen SA; Dún Laoghaire; On-site; EUR 90,000 - 130,000; Full time

Job summary

Amgen is seeking a Process Development expert in Ireland to support NPI, tech transfer, and lifecycle changes for vial and syringe products. You will act as a PD SME, driving regulatory submissions and responding to regulators, while troubleshooting manufacturing issues across sterile operations.

You will develop and transfer drug product processes, support PPQ and validation activities, and collaborate with Operations, Engineering and external vendors to ensure compliant, robust manufacturing.

Qualifications

• Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience OR Master's degree with 3 years of related experience.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills

Responsibilities

• Leads NPI and lifecycle changes into production from a Process Development perspective.
• Acts as PD SME for products after transfer.
• Contributes to regulatory filings and responds to regulator questions.
• Provides technical expertise for parenteral drug product filling, formulation, and device problems.
• Develops and validates drug product processes and supports tech transfer and validation.
• Leads risk assessment and CAPA for drug product operations.
• Interfaces with Operations, Engineering and vendors for validated processes.
• Supports cross-site teams and site validation guidance documents.

Skills

Problem Solving

Communication

Project Management

Leadership

Cross-functional

Quality Systems

cGMP Knowledge

Regulatory Filing

Troubleshooting

Team Collaboration

Education

Bachelor's degree in Science/Engineering

Master's degree in Science/Engineering

Job description

Amgen is seeking a Process Development expert in Ireland to support NPI, tech transfer, and lifecycle changes for vial and syringe products. You will act as a PD SME, driving regulatory submissions and responding to regulators, while troubleshooting manufacturing issues across sterile operations.

You will develop and transfer drug product processes, support PPQ and validation activities, and collaborate with Operations, Engineering and external vendors to ensure compliant, robust manufacturing.