Qualifications

• 5-7 years of experience in commissioning, qualification, and validation within a regulated manufacturing environment.
• Strong CQV (Commissioning, Qualification, Validation) background including IQ, OQ, PQ, and PPQ processes.
• Familiarity with medical device regulations, specifically ISO 13485 and 21 CFR 820.
• Proven ability to manage contractors and oversee project budgets rather than performing execution tasks.
• Experience with cleanroom environments, utilities, and HVAC systems.
• Specific experience in coating, converting, laminating, or web handling processes is preferred.
• Willingness to work onsite in Wisconsin or travel if based out of the area.

Responsibilities

• Own the commissioning, qualification, and validation strategy for the new manufacturing site.
• Lead the qualification of cleanrooms, utilities, HVAC, and process equipment through to Performance Qualification (PQ).
• Oversee the transfer of processes and equipment from the existing site to the new facility.
• Manage the external commissioning, qualification and validation resources, engineering contractors, and equipment vendors.
• Take charge of equipment User Requirements Specifications (URS), as well as Vendor Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Collaborate with quality assurance to establish the site's Quality Management System (QMS), documentation, and regulatory requirements.
• Report project progress, risks, and timelines to senior stakeholders.

Benefits

• Opportunity to lead a major new site start-up, enhancing your resume with high-stakes experience.
• Engage in diverse tasks from managing contractors to deep technical understanding, fostering broad professional growth.
• Work in a regulated industry with a strong emphasis on compliance and quality, providing job security and stability.