PFS Process Engineer
PFS Process Engineer – 4 days on, 4 days off Shift
- Location: Waterford
- Job type: 23 month FTC
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 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised 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.
About the job
This is a “4 days on 4 days off” shift (12 hour shifts, 7am to 7pm).
To provide Process Engineering shift support to existing business as usual daily functions and on-going continuous improvement prefilled 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.
- The main area of work is to provide process engineering support to operations of the PFS sterile syringe filling line located at Sanofi Waterford. This line consists of state-of-the-art technologies including Debagger / Ebeam / Delid / Deline / Grade A Isolator and Syringe filling machine with multi filling technologies.
- Furthermore, support in the delivery of 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.
- 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.
- Support commercial manufacturing through delivery of key performance metrics (SQDCI).
- Degree in an Engineering discipline.
- Strong problem solving skills.
- Strong documentation/protocol generation and execution skills.
- Significant experience in a highly regulated GMP environment.
- Experience of Sterile Manufacturing Operation an advantage.
- Experience in syringe filling would be a distinct advantage.
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