Validation Project Manager

Creative Solutions Services, LLC; Madison (WI); On-site; USD 95,000 - 125,000; Full time

Job summary

Creative Solutions Services, LLC in Wisconsin is seeking an experienced CQV/qualification lead to oversee the commissioning, qualification and validation strategy for a new site.

You will drive IQ/OQ/PQ, PPQ and manage transfers, vendor and contractor oversight, ensuring alignment with QMS and regulatory registrations to support on-time startup. This role requires on-site presence in Wisconsin with a proven track record in regulated manufacturing.

Qualifications

• Experience leading CQV activities in regulated manufacturing environments.
• Strong IQ/OQ/PQ, PPQ, and cleanroom qualifications.
• Familiarity with ISO 13485 and 21 CFR 820 preferred.

Responsibilities

• Own commissioning, qualification and validation strategy for the new site.
• Lead equipment and facility qualification (IQ/OQ/PQ) including cleanrooms, utilities, HVAC.
• Manage process and equipment transfer from the existing site and external CQV resources.

Skills

CQV leadership

Regulatory compliance

Vendor management

Education

Bachelor's degree in engineering or life sciences

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