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Katalyst Healthcares & Life Sciences
Validation Project ManagerKatalyst Healthcares & Life Sciences • Madison, WI, United States
Validation Project Manager

Validation Project Manager

Katalyst Healthcares & Life Sciences • Madison, WI, United States
1 day ago
Job type
  • Full-time
Job description

Job Title

Roles and Responsibilities:

  • Own the commissioning, qualification and validation strategy for the new site
  • Lead equipment and facility qualification through to PQ cleanrooms, utilities, HVAC, process equipment
  • Manage process and equipment transfer from the existing site
  • Manage external CQV resource, engineering contractors and equipment vendors
  • Own facility and equipment URS, vendor FAT and SAT
  • Work alongside quality to get the site's QMS, documentation and regulatory registration in place
  • Report progress, risk and timeline to senior stakeholder

Experience:

  • Experience leading a new site start-up, facility build or full site transfer in a regulated manufacturing environment this is the key one
  • Strong CQV background: IQ/OQ/PQ, PPQ, cleanroom and utilities qualification
  • Medical device background, ISO 13485 and 21 CFR 820
  • Experience managing contractors and capital project budgets, rather than executing protocols yourself
  • Coating, converting, laminating or web handling experience is a real advantage
  • Comfortable being on site in Wisconsin. Candidates outside the area who'd work on a travel basis will be considered
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Validation Project Manager • Madison, WI, United States

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