Validation Project Manager

CAPU Search; Wisconsin; On-site; USD 96,000 - 165,000; Part time

Job summary

CAPU Search is supporting a medical device manufacturer with a new Wisconsin site build, seeking a Site Qualification & Validation Lead to own the CQV program end-to-end. You’ll plan, supervise contractors, and ensure the facility is qualified, audit-ready, and on schedule.

The role emphasizes ownership over commissioning and qualification strategies, PQ through to transfer, and collaboration with quality to achieve ISO 13485 and 21 CFR 820 compliance for a regulated manufacturing environment.

Qualifications

• Experience leading a new site start-up or full site transfer in a regulated manufacturing environment.
• Strong CQV background: IQ/OQ/PQ, PPQ, cleanroom and utilities qualification.
• Medical device background with ISO 13485 and 21 CFR 820.
• Experience managing contractors and capital project budgets; not hands-on protocol execution.

Responsibilities

• Own 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 resources, engineering contractors and equipment vendors.
• Own facility and equipment URS, vendor FAT and SAT.
• Collaborate with quality to prepare QMS, documentation and regulatory registration.
• Report progress, risk and timelines to senior stakeholders.

Skills

CQV leadership

IQ/OQ/PQ

PPQ

ISO 13485

21 CFR 820

Vendor management

Capital project budgeting

Coating / web handling

On-site Wisconsin work

Job description

Site Qualification & Validation Lead – Medical Device (Contract)

We're supporting a medical device manufacturer with a new site build in Wisconsin. Processes and plant are being transferred in, and they need someone to lead the qualification and validation of the site end to end.

This is an ownership role, not a protocol-writing one. You'd be running the programme — planning it, managing the contractors and vendors doing the execution, and making sure the site comes up qualified, on time, and audit-ready.

What the role covers

• 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

What we're looking for

• 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

Details

• Contract, 6 months with likely extension
• Rate:, depending on experience and engagement basis (W2 / 1099 / C2C)