Verista, Inc.
life science
SeniorLabCQVEngineer/SeniorValidationEngineer
“Senior Lab CQV Engineer / Senior Validation Engineer at Verista, Inc.. Skills: CQV, qualification, validation, laboratory equipment, laboratory systems, cGMP, GxP. Execute commissioning, qualification, and validation activities for laboratory instruments and systems. Support qualification of both standalone and integrated laboratory equipment”
What You'll Achieve.
empower growth and innovation within the scientific community; help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges; empower informed decision-making; making an impact every day; client success at every turn; ensure timely project execution
Industry & Context.
problem-solving
on-site role in Muskegon, MI
What They're Looking For.
Must Have
Bachelor's Degree in Engineering, Life Sciences, Computer Science, or related technical discipline, 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, knowledge of equipment qualification lifecycle activities including commissioning, IQ/OQ/PQ execution, deviation management, and change control, Knowledge of 21 CFR Part 11 and GxP compliance expectations, technical writing, communication, organizational, and problem-solving skills, Ability to work independently with minimal oversight while collaborating effectively across functional teams
Nice to Have
Experience working with laboratory instrumentation such as HPLC, GC, TOC analyzers, balances, spectrophotometers, stability chambers, or similar analytical equipment, Understanding of computerized laboratory systems and system integrations, Familiarity with risk-based validation approaches and data integrity requirements
What You'll Do.
Execute commissioning
and validation activities for laboratory instruments and systems
Support qualification of both standalone and integrated laboratory equipment
and execute validation lifecycle documentation
Perform impact assessments and risk assessments
Troubleshoot qualification issues
investigate deviations
and support root cause analysis activities
and compliant qualification documentation
Support system integrations and assess data flow
Coordinate qualification activities with project schedules
How You'll Work.
Team & Collaboration
collaborating with laboratory stakeholders and instrument vendors; Interface directly with laboratory personnel, engineering teams, QA, and instrument vendors; collaborating effectively across functional teams; Coordinate qualification activities with cross-functional stakeholders
Communication Scope
communication
Process & Methodology
Coordinate qualification activities with project schedules
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