Process Engineer in Pre Filled Syringe Manufacturing

Biopharma Careers; Waterford; On-site; EUR 55,000 - 73,000; Part time

Job summary

Sanofi is seeking a Process Engineer for its Waterford, Ireland site to support pre-filled syringe manufacturing from a GMP perspective. The role focuses on batch release, process improvements, and technology transfer across sterile operations with emphasis on quality systems and CAPA closures.

You will contribute to ongoing NPI initiatives, capacity expansions, and continuous improvement projects while collaborating with an integrated Engineering Team in a highly regulated environment.

Qualifications

• Degree in an Engineering discipline.
• Proven problem-solving and documentation skills in GMP environments.
• Experience in sterile manufacturing operations.

Responsibilities

• Own and deliver batch release-related activities for 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).

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.

Equal opportunity statement

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Other information

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

Salary

The salary range for this position is :€54 800,00 - €73 067 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

• Employees may be eligible to participate in Company employee benefit programs.

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