Process Engineer

Summary:

Our client is a biopharmaceutical company based in Waterford looking for a Process Engineer to join its team. The successful candidate will work within the pre-filled syringe team, and will support the manufacturing of monoclonal antibodies (mAb) commercial products, aid technology transfer of new products and introduce capacity enablers.

Responsibilities: The main area of work is to provide process engineering assistance to operations of the sterile syringe filling line. 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, aid 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 help 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. Delivery of key performance metrics (SQDCI) to optimise the commercial manufacturing. Qualifications & Experience: Degree in an Engineering discipline. Significant experience in a highly regulated GMP environment. Strong problem-solving skills, as well as strong documentation/protocol generation and execution skills. Experience of Sterile Manufacturing Operation and syringe filling would be an advantage.
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