6504 - Lab CQV Engineer / Validation Engineer 2

Veristainc; Muskegon (MI); On-site; USD 69,000 - 95,000; Full time

Benefits offered by this job

Competitive pay

401(k) matching

Life, Disabilty, & Medical Insurance

Tuition reimbursement

Paid time off

Job summary

Verista in Muskegon, MI is seeking a Lab CQV / Validation Engineer 2 to qualify and validate laboratory instruments and systems in a regulated life sciences environment. You will execute IQ/OQ/PQ, draft validation docs, and collaborate with QA, engineering, and vendors to ensure data integrity and compliance.

The role focuses on independent CQV execution, risk-based validation, and ensuring alignment with cgmp and 21 CFR Part 11 requirements, with on-site work in Muskegon, MI.

Qualifications

• Bachelor’s degree in engineering, life sciences, CS or related technical discipline preferred.
• 4–6 years of experience in CQV, qualification, validation, or laboratory systems support in pharma/biotech/life sciences.
• Hands-on experience qualifying complex laboratory instruments and systems in a regulated cGMP environment.
• Strong knowledge of qualification lifecycle activities including commissioning, IQ/OQ/PQ, deviation management, and change control.
• Experience with laboratory instruments such as HPLC, GC, TOC analyzers, balances, spectrophotometers, or similar equipment.
• Understanding of computerized laboratory systems and system integrations; focus on equipment qualification and CQV execution.
• Familiarity with risk-based validation and data integrity requirements.
• Knowledge of 21 CFR Part 11 and GxP compliance.
• Strong technical writing, communication, organizational, and problem-solving skills.
• Ability to work independently with minimal oversight while collaborating across cross-functional teams.

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 with laboratory personnel, engineering teams, QA, and instrument vendors to define testing scope and qualification strategy.
• Draft, review, and execute validation lifecycle documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, SummaryReports, 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.
• Maintain accurate, detailed, and compliant qualification documentation per 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 execution.
• Ensure compliance with FDA cGMP guidelines, data integrity expectations, and 21 CFR Part 11 requirements.

Education

Bachelor’s Degree in Engineering, Life Sciences, Computer Science, or related technical discipline

Job description

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 Lab CQV / Validation Engineer 2 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, SummaryReports, 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, organizational, and problem‑solving skills
• Ability to work independently with minimal oversight while collaborating effectively across functional teams

This is a 100% on-site role in Muskegon, MI.

Salary

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job‑related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

National (US) Range

$69,300 — $95,358 USD

About

Verista is an equal opportunity employer.

Benefits

Why Choose Verista?

• High growth potential and fast‑paced organization with a people‑focused culture
• Competitive pay plus performance‑based incentive programs
• Company‑paid Life, Short‑Term, and Long‑Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com