Senior CQV Engineer — Lead Pharma Validation (On-site)

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Tuition Reimbursement

Paid Time Off

Job summary

Verista is seeking a Senior Validation Engineer to lead end-to-end CQV and validation projects for pharma manufacturing, facilities, utilities, and equipment. You will develop core validation deliverables, manage schedules, and collaborate with Engineering, Operations, Quality, and vendors to ensure compliance with GMP and data integrity requirements.

The role requires 5+ years in CQV/validation, strong leadership, and on-site presence in Mount Vernon, IN.

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

GxP

Project Management

Communication

Leadership

Regulatory Compliance

Data Integrity

Veeva

Education

Bachelor’s degree in Engineering, Life Sciences, or related

Tools

Veeva

Job description

Verista is seeking a Senior Validation Engineer to lead end-to-end CQV and validation projects for pharma manufacturing, facilities, utilities, and equipment. You will develop core validation deliverables, manage schedules, and collaborate with Engineering, Operations, Quality, and vendors to ensure compliance with GMP and data integrity requirements.

The role requires 5+ years in CQV/validation, strong leadership, and on-site presence in Mount Vernon, IN.