6504 - Senior Lab CQV Engineer / Senior Validation Engineer

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, 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.

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.

*Verista is an equal opportunity employer.

National (US) Range$69,300—$95,358 USDBenefits

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

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