6330 - Senior Lab CQV Engineer / Senior Validation Engineer

United States·Muskegonsenior

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Execute commissioning, qualification, and validation activities for laboratory instruments and systems,

Requirements Summary

Execute commissioning, qualification, and validation activities for laboratory instruments and systems,

Technical Tools

QA & TestingValidation Engineer

Description

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

Responsibilities

~1 min read

→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

Requirements

~1 min read

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

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

$80,465—$122,603 USD

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

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