Process Engineer Pre- Filled Syringe

• Location: Waterford

About the job

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need.

To provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre filled syringe processes. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 works together at a state-of-the-art biopharmaceutical and medical device campus. Recognized through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical Centre that underpin a strong commitment to health and wellbeing.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• The main area of work is to provide support on the existing Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
• Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.
• Own and deliver projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualification.
• Support commercial manufacturing through delivery of key performance metrics (SQDCI).

Requirements

To excel in this role you will need:

• Degree in an Engineering discipline.
• Strong problem solving skills.
• Strong documentation/protocol generation and execution skills.
• 3 or more years’ relevant experience in a highly regulated GMP environment. 
• Experience of Sterile Manufacturing Operations.
• Experience in syringe filling would be a distinct advantage.

Beneficial but not Essential:

• Cleaning verification/validation experience.
• Experience with various forms of filtration and associated filter integrity testing.
• Autoclave & Parts washer knowledge.
• Experience in sterile manufacturing.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.

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