Senior Process Development Engineer, Sterile Filling & SUS

Amgen; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Engineer, Process Development to lead filling process characterization and qualification for two new syringe lines, including single-use technologies. The role supports site expansion, technology transfer, validation, and manufacturing with a data-driven, compliant approach.

You will mentor engineers, drive cross-functional reviews, and ensure safety, quality, and regulatory alignment across the network, contributing to strategic objectives.

Qualifications

• Bachelor's or higher in science/engineering with process development exposure.
• Experience with aseptic filling and single-use technologies.
• Strong knowledge of cGMP and regulatory expectations.

Responsibilities

• Lead filling process characterization activities and protocol design.
• Provide technical leadership for qualification and deployment of filling technologies.
• Support technology transfer, process validation, and commercial manufacturing.
• Troubleshoot process, equipment, and product performance issues using data-driven methods.
• Collaborate with manufacturing, QA, regulatory, and external partners.

Skills

Process development leadership

Aseptic filling

Single-use technologies

cGMP compliance

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering

Master's degree preferred

Tools

Statistical analysis tools

Job description

Amgen Dun Laoghaire is seeking a Senior Engineer, Process Development to lead filling process characterization and qualification for two new syringe lines, including single-use technologies. The role supports site expansion, technology transfer, validation, and manufacturing with a data-driven, compliant approach.

You will mentor engineers, drive cross-functional reviews, and ensure safety, quality, and regulatory alignment across the network, contributing to strategic objectives.