6495 - Senior CQV Engineer / Senior Validation Engineer

United States·Mount Vernonsenior

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Lead and drive end-to-end CQV and validation projects for pharmaceutical manufacturing, facility, utility, and equipment systems, from planning through execution, closeout, and final approval Develop,

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

→Lead and drive end-to-end CQV and validation projects for pharmaceutical manufacturing, facility, utility, and equipment systems, from planning through execution, closeout, and final approval
→Develop, review, and manage core validation deliverables, including Validation Plans, DQ, Data Integrity Assessments, FAT, IQ/OQ, PQ, Commissioning, Validation Reports, and associated summaries
→Partner with Engineering, Project Management, Operations, Quality, SMEs, and vendors to define requirements, coordinate project activities, manage dependencies, and maintain validation schedules
→Author and execute FAT, IQ/OQ, PQ, and Commissioning protocols, coordinating equipment availability, personnel, materials, calibrations, and required downtime to support successful testing
→Lead validation document reviews, consolidate and resolve comments, and manage Veeva or comparable document management workflows through pre-approval, execution, and final approval
→Identify, investigate, and resolve deviations, exceptions, discrepancies, and testing issues, coordinating corrective actions, approvals, and required retesting
→Ensure all CQV activities and documentation comply with GxP/cGMP, data integrity, risk-based validation principles, company procedures, and applicable regulatory requirements
→Serve as a senior validation lead, proactively communicating project status, risks, schedule impacts, and critical issues, while independently managing multiple CQV workstreams and driving projects to successful completion

Requirements

~2 min read

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
5+ years of experience in CQV, validation, commissioning, or engineering within pharmaceutical, biotechnology, or other regulated industries
Demonstrated experience leading end-to-end CQV/validation projects, including planning, document development, execution, issue resolution, and validation closeout
Strong hands-on experience developing and executing DQ, DIA, FAT, IQ/OQ, PQ, commissioning, Validation Plans, and Validation Reports for equipment, utilities, facilities, or manufacturing systems
Proven ability to drive cross-functional validation activities, coordinating Project Management, Engineering, Operations, Quality, SMEs, vendors, and other stakeholders to maintain schedules and resolve issues
Strong understanding of GMP, GxP, data integrity, risk-based validation, qualification principles, and applicable regulatory requirements
Experience with Veeva or comparable electronic document management/quality systems, including document routing, review, comment resolution, approval, and validation record management
Strong project management, communication, organizational, troubleshooting, and leadership skills, with the ability to independently manage multiple validation workstreams and deliverables in a fast-paced regulated environment
Must be willing to be on-site 100% in Mount Vernon, IN

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

$78,925—$110,000 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