Process Engineer – PFS
About the job
To provide Process Engineering support to existing business as usual daily functions and ongoing continuous improvement pre-filled syringe processes across both commercial lines. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support the introduction of capacity enablers and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.
About Sanofi Business Unit
The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 800 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.
Main responsibilities:
* The main area of work is to provide day shift support on the existing Aseptic Syringe Filling Lines 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 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).
About you
* 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 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?
* Working with state-of-the-art technology.
* Introducing new products to site.
* Process ownership of projects from start to finish.
* Supporting commercial manufacturing to provide patients with products.
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