Job Description
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 own and deliver batch release related activity for the 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. Assist with projects, which works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to facilitate 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 activities will include helping on the existing Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies. Delivery of key performance metrics (SQDCI) to optimise the commercial manufacturing. Qualifications & Experience: Degree in an Engineering discipline. Experience in a highly regulated GMP environment. Background in batch release, root cause analysis and investigation exposure. Eexperience in syringe/vial filling and inspection and/or in sterile manufacturing. Strong problem solving and communication skills. Strong documentation/protocol generation and execution skills. Skills: cGMP Batch release