Senior Lab CQV Engineer: Validate & Qualify Lab Equipment

Muskegon, MI

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Job Overview: We are seeking a skilled Senior Lab CQV / Senior Validation Engineer with hands-on experience qualifying and validating a wide range of laboratory equipment and systems within a regulated pharmaceutical or life sciences environment. The ideal candidate will have direct experience executing commissioning and qualification activities independently, collaborating with laboratory stakeholders and instrument vendors, and supporting lifecycle validation activities for both simple and complex laboratory instrumentation.

Job Responsibilities:

• Execute commissioning, qualification, and validation activities for laboratory instruments and systems, including IQ/OQ/PQ execution and protocol development
• Support qualification of both standalone and integrated laboratory equipment, including analytical and computerized laboratory systems
• Interface directly with laboratory personnel, engineering teams, QA, and instrument vendors to define testing scope, acceptance criteria, and qualification strategy
• Draft, review, and execute validation lifecycle documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Summary Reports, deviations, and change controls
• Perform impact assessments and risk assessments to determine system criticality, GxP impact, and qualification requirements
• Troubleshoot qualification issues, investigate deviations, and support root cause analysis activities during execution
• Maintain accurate, detailed, and compliant qualification documentation in accordance with cGMP and internal quality standards
• Support system integrations and assess data flow between laboratory instruments, software platforms, and enterprise systems
• Coordinate qualification activities with project schedules and cross-functional stakeholders to ensure timely project execution
• Ensure compliance with applicable regulatory requirements including FDA cGMP guidelines, data integrity expectations, and 21 CFR Part 11 requirements

Job Requirements:

• 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,…