KH
Validation Project Manager
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Manager or above
2 weeks ago
- HVAC
2 weeks ago
Not enough detail in this posting to match
- 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
Validation Project Manager · Katalyst Healthcares & Life Sciences