Process Engineer in Pre Filled Syringe Manufacturing

Sanofi; Munster; On-site; EUR 60,000 - 75,000; Full time

Job summary

Sanofi is seeking a Process Engineer for the Waterford, Ireland site to support pre-filled syringe manufacturing operations in a sterile GMP environment.

In this fixed-term 23-month contract, you will drive batch release activities, support continuous improvement, and ensure compliance with quality and safety standards across thawing, filling, and related processes.

Qualifications

• Degree in an Engineering discipline.
• Strong problem-solving skills.
• Strong documentation, protocol generation and protocol execution skills.
• Demonstrable relevant experience in a highly regulated GMP environment.
• Experience in Sterile Manufacturing Operations.

Responsibilities

• Own and deliver batch release activities for PFS Fill Operations, incl. investigations, root-cause analysis, CAPA, and batch comments.
• Support continuous improvement projects across thawing, formulation, filling, test, and autoclave operations for NPI and capacity expansion.
• Execute Process Engineering activities, including cycle development, reports, deviations, change controls, and compliance.
• Provide process engineering support for aseptic syringe filling line equipment and technologies.
• Support commercial manufacturing through key performance metrics (SQDCI).

Skills

Problem solving

Documentation

GMP experience

Sterile manufacturing

Education

Engineering degree

Job description

Job Title: Process Engineer (Pre-Filled Syringe Manufacturing)

• Location: Waterford, Ireland
• Job Type: 23-month Fixed Term Contract
• Work Arrangement: On-site
• Shift: Standard Days Role

About The Job

As a Process Engineer, you will provide engineering support for existing business-as-usual operations and ongoing continuous improvement initiatives within pre-filled syringe manufacturing processes. You will support the manufacture of commercial monoclonal antibody (mAb) products, contribute to the technology transfer of new products, and assist with the introduction of capacity-enhancing initiatives. Working as part of a highly focused and integrated Engineering Team, you will play a key role in maintaining and optimizing processes within a sterile manufacturing environment.

Ready to get started?

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• Own and deliver batch release-related activities to support PFS Fill Operations, including investigations, root cause analysis, CAPA generation and closure, work order investigations, and addressing batch comments from the Quality team.
• Support continuous improvement projects within thawing, formulation, filling, filter integrity testing, and wash/autoclave operations to support New Product Introduction (NPI) and capacity expansion initiatives including but not limited to single-use technology vendor selection, component introduction, and qualification activities.
• Execute Process Engineering activities, including cycle development protocols and reports, project improvements, deviation management, problem solving, and change controls, ensuring compliance with applicable quality and safety standards.
• Provide Process Engineering support for the existing aseptic syringe filling line, including Debagger, Ebeam, Delid, Deline, Isolator, and syringe filling equipment utilizing multiple filling technologies.
• Support commercial manufacturing through the delivery of key performance metrics (SQDCI).

About You

• Degree in an Engineering discipline.
• Strong problem-solving skills.
• Strong documentation, protocol generation and protocol execution skills.
• Demonstrable relevant experience in a highly regulated GMP environment.
• Experience in Sterile Manufacturing Operations.

Beneficial But Not Essential

• Batch release experience.
• Exposure to root cause analysis and investigation.
• Experience in syringe and/or vial filling and inspection would be a distinct advantage.

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.