Validation Project Manager

Katalyst CRO; Madison (WI); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking an experienced CQV/validation lead for a new site in Wisconsin. You will own commissioning, qualification and validation strategies, and manage transfers from the existing site while coordinating with external CQV resources and contractors.

Responsibilities include leading IQ/OQ/PQ, PPQ, cleanroom and utilities qualification, and aligning with QMS, documentation and regulatory registration. On-site presence in Wisconsin is required.

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 knowledge.
• Experience managing contractors and capital project budgets rather than performing protocols personally.

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.

Skills

CQV background

New site start-up

Contractor management

Budget management

Travel on-site

Tools

URS

FAT

SAT

IQ/OQ/PQ

Job description

• 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

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