Process Engineer

Website TPM04868

Our client is a global bio pharma company based in Waterford seeking a Process Engineer who will be responsible for the qualification of new equipment into commercial manufacturing.


  • 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.
  • Investigation/trouble shooting and solution implementation on process and equipment deviations using GPS3 problem solving tools.
  • Monitoring and review of equipment cycle trends using PI application.
  • Assist in the implementation of capital projects.
  • Implement and monitor performance metrics.
  • Lead technical problem resolution & RCA (Root Cause Analysis) for all manufacturing operations, in conjunction with cross functional teams.
  • Lead cycle time reduction initiatives in conjunction with manufacturing teams.
  • 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.
  • Lead Process Engineering tech transfer activities for product introduction / transfer to the MFFL Line.
  • Provide engineering support to other areas of the MFFL process such as Dispensing, Formulation, Autoclaving and Washing.
  • Provide technical support to implement process improvements, new product transfers to the site and production.
  • Design and implement Process development programs through plant trials, execution and change implementation.
  • Constantly seek to challenge operational standards and driving continuous improvement.

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.
  • Strong leadership skills.
  • Strong Technical Writing skills.
  • Strong coordination, project management and planning skills.
  • Strong understanding of maintenance, reliability, safety, quality and regulatory.
  • Experience with change control, deviation management and associated compliance activities and systems.

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