What are the responsibilities and job description for the Senior CQV Engineer position at QvalFocus Inc.?
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
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.
- 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.