CQV Engineer

Job Title: CQV Engineer

Location: Raleigh-Durham-Chapel Hill Area (NC)

What You Will Do

Support the preparation and execution of commissioning and qualification (IQ/OQ) protocols for clean utilities and downstream process equipment.

Perform P&ID walkdowns, loop checks, component verifications, and functional testing.

Participate in FAT/SAT activities, verify equipment installation, track punchlist items, and assist in issue resolution.

Assist with the generation of turnover packages (TOPs), traceability matrices, and other supporting documentation.

Collaborate closely with QA, automation, and construction teams to ensure systems are delivered in accordance with cGMP and project requirements.

Document and escalate deviations; support timely resolution and closeout.

Current Priorities

Downstream processes – primary area of focus

Senior-level experience in protocol execution and closeout

Cleanroom expertise , including:

Clean Utilities

CIP Systems

DeltaV Automation

Experience with Upstream processes and HVAC Cleanroom systems is a plus

Qualifications

• Bachelor's degree in Life Sciences or Engineering (Mechanical, Electrical, Chemical), or equivalent relevant experience.

• Minimum 5 years of experience in commissioning, qualification, and validation (CQV).

• Proficiency with Kneat for protocol development, execution, and documentation.

• Strong understanding of P&IDs, engineering drawings, and protocol execution practices.

• Familiar with cGMP, ASTM E2500, and risk-based CQV methodologies.

• Excellent communication, technical writing, and organizational skills.

• Able to work independently and collaboratively in a team-oriented environment.