Process Engineer


Waterford, Ireland

About the job

To provide Process Engineering shift support to existing business as usual daily functions and on-going continuous improvement prefilled syringe processes. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Main responsibilities

  • The main area of work is to own and deliver batch release related activity to support the PFS 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.
  • In addition, supporting projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support 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 responsibilities will be to provide support on the existing Aseptic Syringe Filling Line which includes Debagger/Ebeam/Delid/Deline/Isolator/Syringe filling machine with multi filling technologies.
  • Support commercial manufacturing through delivery of key performance metrics (SQDCI).

About you

Essential requirements:

  • 1+ more years’ relevant of experience in a highly regulated GMP environment
  • Degree in an Engineering discipline
  • Strong problem solving and communication skills
  • Strong documentation/protocol generation and execution skills

Beneficial but not Essential:

  • Batch release experience
  • Root cause analysis and Investigation exposure
  • Experience in syringe/vial filling & inspection would be a distinct advantage
  • Experience in sterile manufacturing

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