Process Engineer

Requirements

  • Operational support for a GMP manufacturing site.
  • Supporting/troubleshooting equipment/systems.
  • Large scale mammalian cell culture operations.
  • Experience with updating and revising MFG SOP’s and Batch records.
  • Familiar with Single Use Technology a plus.
  • Familiar with Delta V operating systems.
  • Tech Transfer experience.
  • Familiarity with Engineering & Manufacturing Systems Lifecycle approach.
  • Familiar with CAPAs, deviations, and change control protocols.
  • Ability to work independently on projects with applicable client stakeholders in Validation, Quality Assurance, Manufacturing, Maintenance, and other relevant personnel.
  • Takes ownership of assignments, can work both independently and as part of the team.
  • Ability to work in a fast-paced and challenging environment.
  • Strongly motivated, well-organized, and shows professional initiative.
  • Excellent organization skills with the ability to manage multiple tasks simultaneously.