6495 - Senior CQV Engineer / Senior Validation Engineer

Verista; Mount Vernon (IN); On-site; USD 79,000 - 110,000; Full time

Benefits offered by this job

Growth potential

Competitive pay

Life/Disability Insurance

Medical/Dental/Vision

401(k) Matching

Paid Time Off

Parental Leave

Tuition Reimbursement

Team events

Job summary

Verista in Mount Vernon, IN is seeking a Senior Validation Engineer to lead end-to-end CQV projects for pharmaceutical manufacturing, utilities, and equipment systems. You will drive planning, execution, and final approval while coordinating with engineering, operations, quality, and vendors.

The role requires a Bachelor's in Engineering or Life Sciences and 5+ years in CQV/validation in regulated settings.

Qualifications

• 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

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, 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.

Skills

CQV

Validation

Project management

GxP/GMP

Veeva

Cross-functional leadership

Documentation

Regulatory knowledge

On-site

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Veeva

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

Senior Validation Engineer 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, 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

Job Requirements

• 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 USD - $110,000 USD

Benefits

• 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