CONTRACT TYPE - Full time
JOB ID - R2710251
LOCATION - Waterford, Ireland
Process Engineer - PFS
About the Opportunity
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.
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 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 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)
- Degree in an Engineering discipline
- Strong problem solving skills
- Strong documentation/protocol generation and execution skills
- Significant experience in a highly regulated GMP environment
- Well-established background in Sterile Manufacturing Operations
- Experience in syringe filling would be a distinct advantage
- Cleaning verification/validation experience
- Experience with various forms of filtration and associated filter integrity testing
- Autoclave & Parts washer knowledge
- Experience in sterile manufacturing
- 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
Empower Life Everyday.
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
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, disability, or gender identity.
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