Senior Process Development Engineer, Sterile Filling

Amgen; Ireland; On-site; EUR 110,000 - 140,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) seeks a Senior Engineer, Process Development to provide technical leadership for syringe filling lines, supporting site expansion, process characterization, and SUS implementation for two new lines.

The role requires strong cross-functional collaboration, data-driven decision making, and experience in aseptic filling, cGMP compliance, and technology transfer to manufacturing. You will mentor junior engineers and represent Process Development in governance forums.

Qualifications

• Bachelor’s or higher in science/engineering with relevant experience.
• Strong knowledge of cGMP and regulatory expectations.
• Experience with aseptic filling and process development activities.

Responsibilities

• Lead and support filling process characterization activities and reporting.
• Provide technical leadership for filling technologies and SUS.
• Support technology transfer, validation, and manufacturing activities.
• Troubleshoot process, equipment, and product issues with data-driven methods.
• Lead investigations, CAPA, risk assessments, and deviation management.
• Collaborate with cross-functional teams to ensure alignment and readiness.

Skills

cGMP knowledge

Aseptic manufacturing

Process development

Cross-functional collaboration

Data-driven decision making

Technical leadership

Problem solving

Regulatory familiarity

Education

Bachelor's in Science/Engineering

Master's degree

PhD preferred

Tools

Single-use technologies (SUS)

Peristaltic pump filling systems

Job description

Amgen Dun Laoghaire (ADL) seeks a Senior Engineer, Process Development to provide technical leadership for syringe filling lines, supporting site expansion, process characterization, and SUS implementation for two new lines.

The role requires strong cross-functional collaboration, data-driven decision making, and experience in aseptic filling, cGMP compliance, and technology transfer to manufacturing. You will mentor junior engineers and represent Process Development in governance forums.