Validation Project Lead - New Site Start-up & CQV

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

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.