CQV Engineer

CQV Engineers (2 Contract Positions) – Medical Device Equipment

Location: Chaska, Minnesota (Onsite)

Contract Lengths: 1 x 3-Month Contract & 1 x 18-Week Contract

Rate: Up to $60/hour (Depending on Experience)

US CITIZENS OR GREENCARD HOLDERS ONLY, NO SPONSORSHIP.

We are seeking two experienced Commissioning, Qualification & Validation (CQV) Engineers to support a leading medical device manufacturing facility in Chaska, Minnesota. These are fully onsite contract opportunities supporting both new and existing manufacturing equipment within a regulated GMP environment.

Successful candidates will play a key role in the commissioning, qualification, and validation of medical device manufacturing equipment, ensuring compliance with FDA and quality standards while supporting production readiness.

Responsibilities

• Execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment.
• Support qualification of both new installations and legacy equipment.
• Develop, review, and execute validation protocols and reports.
• Perform equipment risk assessments and impact assessments.
• Troubleshoot qualification issues and work closely with engineering and manufacturing teams to resolve deviations.
• Ensure all validation documentation complies with GMP, FDA, and internal quality requirements.
• Support change controls, CAPAs, and non-conformance investigations where required.
• Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, and Validation.

Requirements

• Bachelor's degree in Engineering or a related technical discipline (or equivalent industry experience).
• Proven CQV experience within the medical device, pharmaceutical, or life sciences industry.
• Strong experience qualifying manufacturing equipment in a regulated GMP environment.
• Experience writing and executing IQ/OQ/PQ protocols.
• Working knowledge of FDA regulations, cGMP, GAMP, and validation best practices.
• Strong documentation, communication, and problem-solving skills.
• Ability to work independently while collaborating within a multidisciplinary team.

Preferred Experience

• Medical device manufacturing experience preferred.
• Experience with automated manufacturing equipment is advantageous.
• Familiarity with change control and quality systems.

Contract Details

• 2 Positions Available
• 1 x 3-Month Contract
• 1 x 18-Week Contract
• Fully onsite in Chaska, Minnesota.
• Immediate start preferred.
• Competitive hourly rate of up to $60/hour, depending on experience.

If you're an experienced CQV Engineer looking to support a high-profile medical device project, we'd love to hear from you.