Process Engineer Pre Filled Syringe
Company: Sanofi
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 700 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.
The Role
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.
This role would also offer the perfect opportunity for a recent Engineering Graduate to progress their career and gain significant experience within a biopharmaceutical and medical device campus.
Key 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)
Essential Requirements
- 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
What Sanofi Can Offer You
- Working with state of the art technology
- Introducing new products to site
- Process ownership of projects start to finish
- Supporting commercial manufacturing to provide patients with products
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.
