Process Engineer in Pre Filled Syringe Manufacturing

Reposted 4 Hours Ago
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Waterford, MI, USA
In-Office
55K-73K Annually
Mid level
Healthtech
The Role
Provide process engineering support for pre-filled syringe sterile manufacturing of commercial mAb products. Drive batch-release activities, investigations, CAPA, cycle development, NPI and capacity expansion, vendor/component qualification, and continuous improvement for filling, thawing, formulation, filter testing, and wash/autoclave operations while ensuring GMP compliance.
Summary Generated by Built In

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.

#LI-EUR

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.

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.

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

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.

Skills Required

  • 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.

Sanofi Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sanofi and has not been reviewed or approved by Sanofi.

  • Retirement Support Retirement support stands out through a notably strong 401K matching structure (e.g., 150% match up to a 6% contribution), which materially boosts total rewards for long-tenured employees.
  • Parental & Family Support Parental and family support is positioned as unusually robust, including a global gender-neutral paid parental leave standard (14 weeks) and added supports such as childcare assistance and adoption/surrogacy/infertility help.
  • Equity Value & Accessibility Equity participation is made more accessible via an Employee Stock Purchase Plan that includes a meaningful purchase discount and matching/free-share mechanics, increasing perceived total compensation beyond base pay.

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The Company
HQ: Paris
85,000 Employees
Year Founded: 1973

What We Do

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms

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