- Location: Waterford, Ireland
- Job Type: 23-month Fixed Term Contract
- Work Arrangement: On-site
- Shift: Standard Days Role
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.
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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).
- 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.
- Batch release experience.
- Exposure to root cause analysis and investigation.
- Experience in syringe and/or vial filling and inspection would be a distinct advantage.
- 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.
