Job Description
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
Skills
Capital Budgetingunmatched
Capital Projectunmatched
Cleanroomunmatched
Code of Federal Regulationsunmatched
Commissioningunmatched
Documentationunmatched
HVACunmatched
ISO (International Organization for Standardization)unmatched
Leadershipunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Process Managementunmatched
Process Validationunmatched
Project/Program Managementunmatched
Regulationsunmatched
Startupunmatched
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