Senior CQV Engineer
QvalFocus Inc. · Wichita, KS · 1 wk ago
On-siteEngineeringContract
Location: Wichita, KS Experience: 5+ Years Job Type: Contract Job Summary We are seeking a Senior CQV / Validation Engineer to support commissioning, qualification, and validation activities within a GxP-regulated pharmaceutical, biotech, medical device, or life sciences environment. The ideal candidate will have strong hands-on experience with CQV execution, IQ/OQ/PQ, commissioning, validation documentation, and field testing. Key Responsibilities Lead and support commissioning, qualification, and validation (CQV) activities for facilities, utilities, manufacturing equipment, laboratory systems, and computerized systems.Author, review, and execute URS, risk assessments, qualification plans, IQ/OQ/PQ protocols, test scripts, and validation reports.Perform hands-on field execution, system walkdowns, functional testing, field verification, and acceptance testing.Identify and support resolution of deviations, discrepancies, change controls, and punch-list items.Review engineering drawings, P&IDs, equipment specifications, vendor documentation, and test records.Collaborate with Engineering, Quality, Operations, Automation, and vendors to support project schedules and qualification activities.Ensure all CQV activities comply with cGMP, GAMP 5, ASTM E2500, GDP, ALCOA+, and data integrity requirements.Track project deliverables, risks, issues, and qualification status while maintaining accurate documentation. Requirements Bachelor s degree in Engineering, Life Sciences, or a related technical field.5+ years of hands-on CQV/Validation experience in a regulated life sciences environment.Strong experience with IQ/OQ/PQ, commissioning, qualification protocols, and field execution.Experience with facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems.Knowledge of cGMP, GAMP 5, ASTM E2500, risk-based qualification, and ALCOA+.Experience with deviations, change controls, punch-list management, and qualification issue resolution.Strong technical writing, documentation, communication, and problem-solving skills.