Validation Project Manager – Site Commissioning, Qualification & Validation

Job overview

The Validation Project Manager – Site Commissioning, Qualification & Validation role is onsite in Madison, WI; compensation is not specified. The role supports a new site in a regulated manufacturing environment. The project manager owns the commissioning, qualification, and validation strategy for the new site, coordinating facility and equipment qualification and transfer activities. The role helps prepare the site’s quality management system, documentation, and regulatory registration while tracking progress, risks, and timelines for senior stakeholders.

What you'll do

• Own the commissioning, qualification, and validation strategy for the new site
• lead equipment and facility qualification through performance qualification, including cleanrooms, utilities, HVAC, and process equipment
• manage process and equipment transfer from the existing site
• manage external CQV resources, engineering contractors, and equipment vendors
• own facility and equipment user requirements specifications and vendor FAT/SAT
• work with Quality on the site QMS, documentation, and regulatory registration
• report progress, risks, and timelines to senior stakeholders.

What we're looking for

Skills & competencies

validation project manager

commissioning

qualification

validation

cqv

site start-up

madison wi

cleanrooms

utilities

hvac

medical devices

iso 13485

Work arrangement

• Weekend coverage required

Why this role

Experience leading a new site start-up, facility build, or full site transfer in a regulated manufacturing environment is identified as key. Strong CQV background, medical device experience, ISO 13485, and 21 CFR 820 are specified; candidates outside the area willing to work on a travel basis will be considered.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.