- Location: Waterford
- Job type: FTC – day role, no shift
About the job
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.
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.
- The main area of work is to own and deliver batch release related activity to support the PFS Fill and Inspection Operations - such as investigations, Root cause analysis, CAPA generation and closure, work order investigations and addressing batch comments from the quality team.
- In addition, supporting 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.
- Other responsibilities will be to provide support on the existing Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
- Support commercial manufacturing through delivery of key performance metrics (SQDCI).
- 1+ more years’ relevant of experience in a highly regulated GMP environment
- Degree in an Engineering discipline
- Strong problem solving and communication skills
- Strong documentation/protocol generation and execution skills
Beneficial but not Essential:
- Batch release experience
- Root cause analysis and Investigation exposure
- Experience in syringe/vial filling & inspection would be a distinct advantage
- Experience in sterile manufacturing
What we offer
- A role where you are instrumental to creating best practice and as the organisation grows, you can too
- We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us
- We have highly subsidised restaurant with free tea and coffee
- A newly refurbished gym is available onsite for a small and highly competitive annual membership fee
- Parking available onsite
- We support flexible working
- Opportunity to work with state of the art technology and grow in commercial manufacturing environment (batch release within a GMP facility) to provide patients with products
If the description fits your experience and has aroused your interest, please apply so we can get in contact with you!
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