Validation Project Manager

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