Process Engineer

2 weeks ago


Sligo, Sligo, Ireland TN Ireland Full time

PE Global is currently recruiting for a Process Engineer for a leading biopharmaceutical client based in Sligo.

This is an initial 12-month contract position.

Role
  • Process Engineer for Fill Finish Manufacturing site.
  • Leverage detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification.
  • Responsible for single use design, onboarding, and qualification. Act as site representative on cross-site teams for standardization of single-use assemblies and procedures. Work with supplier technical teams to maintain a good relationship. Technical representative on site cross-functional team for design updates and introduction of new single use to site.
  • Author of process flow diagrams for new product introductions / technology transfers. Responsible for aligning PFD between products and standardizing for NPI. Aligns with NPI Lead for product transfer on requirements for new products or process improvements.
  • Technical SME for investigations, responsible for process improvements and monitoring of process efficiency.
  • Author gap assessments, facility fit studies, process safety, and risk assessments for NPI.
  • Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.
  • Understand and ensure compliance with safety, regulatory, and compliance expectations.
  • Other duties as assigned.
Requirements
  • Third level degree in Chemical Engineering or Bioprocess Engineering.
  • 3-5 years' experience in the biopharmaceutical industry.
  • Biologics experience with at-scale manufacturing in a fill finish facility in a technical role.
  • Experience with new product introductions / technology transfers to fill finish manufacturing facility.
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