6330 - Senior Lab CQV Engineer / Senior Validation Engineer
$80,465–$122,603 year
On-site · Wayne, Pennsylvania, United States
Job Summary
Senior Lab CQV Engineer / Senior Validation Engineer responsible for planning and executing commissioning, qualification, and validation activities for laboratory instruments and systems in a regulated life sciences setting. Includes IQ/OQ/PQ execution and protocol development, qualification of standalone and integrated equipment, collaboration with laboratory personnel, engineering teams, QA, and vendors to define testing scope and acceptance criteria, drafting and executing validation lifecycle documentation (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Summary Reports, deviations, change controls), performing risk and impact assessments, investigating deviations, maintaining compliant qualification documentation per cGMP and internal quality standards, supporting data flow assessments across instrument software and enterprise systems, coordinating activities with project schedules and cross-functional stakeholders, and ensuring compliance with FDA cGMP, data integrity, and 21 CFR Part 11 requirements. This is an on-site role in Muskegon, MI, with a US salary range of $80,465—$122,603 USD.
Required Qualifications
- Bachelor’s Degree in Engineering, Life Sciences, Computer Science, or related technical discipline preferred
- 4–6 years of experience in CQV, qualification, validation, or laboratory systems support within the pharmaceutical, biotech, or life sciences industry
- Direct hands-on experience qualifying complex laboratory instruments and systems in a regulated cGMP environment
- Strong knowledge of equipment qualification lifecycle activities including commissioning, IQ/OQ/PQ execution, deviation management, and change control
- Experience working with laboratory instrumentation such as HPLC, GC, TOC analyzers, balances, spectrophotometers, stability chambers, or similar analytical equipment preferred
- Understanding of computerized laboratory systems and system integrations is preferred, but primary focus is on equipment qualification and CQV execution
- Familiarity with risk-based validation approaches and data integrity requirements
- Knowledge of 21 CFR Part 11 and GxP compliance expectations
- Strong technical writing, communication, organizational, and problem-solving skills
- Ability to work independently with minimal oversight while collaborating effectively across functional teams
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