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Process Engineer

3 months ago


Sligo, Sligo, Ireland Cpl Full time

On behalf of our Manufacturing Client in Sligo, we are currently sourcing a Process Engineer to join their team on a 2 years contract basis.

Process Engineer – Fill Finish

Responsibilities

  • 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 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, Bioprocess Engineering 3-5 years' experience in biopharmaceutical industry.

Essential

  • Biologics experience with at scale manufacturing in fill finish facility in a technical role.
  • Experience with new product introductions / technology transfers to fill finish manufacturing facility.
  • Experience in single use technology
  • Experience in isolator technology
  • Experience in SAP / Trackwise

If you have the above skills & experience please contact or Tele:

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