Validation Project Manager

Katalyst Healthcares & Life Sciences

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Information Technology , Management

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