Process Engineer

Website TPM05479

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.

To apply for this job email your details to Orla.daly@tandempm.ie.