6495 - Senior CQV Engineer / Senior Validation Engineer

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