Manufacturing Efficiency Specialist

2 weeks ago


Sligo, Sligo, Ireland beBeeProcess Full time €90,000 - €120,000
Project Process Engineer

Key Responsibilities:

  • Leverage your in-depth knowledge of aseptic fill finish manufacturing to drive input into equipment commissioning and qualification.
  • Responsible for the development, onboarding, and qualification of single-use assemblies.
  • Act as a technical representative on cross-site teams for standardization of single-use procedures.
  • Collaborate with supplier technical teams to maintain effective relationships.
  • Technical representative on site cross-functional team for design updates and introduction of new single use to site.
  • Author 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 stakeholders.

Requirements:

  • 3+ years biologics experience in aseptic processes, experience in single-use technology and isolator technology.
  • 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.


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