Process Engineer

Summary:
Our client is a biopharmaceutical company based in Waterford looking for a Process Engineer to join it’s 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.
• Experience in syringe/vial filling and inspection and/or in sterile manufacturing.
• Strong problem solving and communication skills.
• Strong documentation/protocol generation and execution skills.