Project Manager (Ground Up Projects) Jobot
Madison, WI6 days ago
- $115,000–$140,000 Per Year
Highlights
Experience: Experience leading a new site start-up, facility build or full site transfer in a regulated manufacturing environment — this is the key one. Lead equipment and facility qualification through to PQ — cleanrooms, utilities, HVAC, process equipment.
Numbers & Facts
| Location | Madison, WI |
Description
Roles and Responsibilities :
Experience :
- 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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