Shoolin Inc

Compensation

Full Description

Job Title: CQV Engineer Location: Concord, NC (Onsite) Overview: Seeking a CQV Engineer to support commissioning, qualification, and validation activities in a GMP pharmaceutical manufacturing environment. This is a hands-on, execution-focused role responsible for protocol execution, field testing, documentation, and deviation support for sterile manufacturing equipment and processes. Required Experience: • Hands-on CQV / Validation experience in a GMP pharmaceutical or biotech environment • Execution of IQ, OQ, and PQ protocols • Experience validating autoclaves, parts washers, or isolator filling systems • Strong understanding of GMP and FDA regulatory requirements • GMP documentation and technical writing experience Key Responsibilities: • Execute IQ, OQ, and PQ protocols for pharmaceutical equipment and processes • Perform hands-on validation testing of autoclaves, parts washers, and isolator filling systems • Support process and equipment validation activities in GMP environments • Document test execution results in compliance with site procedures and GMP standards • Identify, document, and support resolution of deviations and test discrepancies