Process Engineer

Website Ref: TPM03947

Summary:
Our client is a global Biologics company based in the South East, looking for a Process Engineer who will provide support to the Multi Format Filling Line (MFFL) line for the aseptic processing of monoclonal antibody (mAb) commercial products. Support technology transfer of new products and provide Process Engineering support to the Multi Format Filling Line (MFFL) line for the aseptic processing of monoclonal antibody (MABS) commercial products.

Responsibilities:

  • Support commercial manufacturing through delivery of key performance metrics.
  • 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.
  • The main area of work would be on the Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
  • Provide engineering support to other areas of the process such as Dispensing, Formulation, Autoclaving and Washing.
  • Provide technical support to implement process improvements, new product transfers to the site and production.

Qualifications & Experience:

  • Honours degree in an Engineering discipline.
  • 3 or more years’ relevant experience in a highly regulated GMP environment.
  • Experience of Sterile Manufacturing Operations would be an advantage.
  • Experience in syringe filling would be a distinct advantage.

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