Senior Validation Engineer

Responsibilities: Lead validation strategy and execution for manufacturing systems, equipment, automation platforms, and production processes, ensuring successful completion of Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV) activities. Develop, review, and approve key lifecycle validation deliverables including Validation Plans, Project Quality Master Plans, protocols, reports, risk assessments, and supporting technical documentation. Drive investigation activities related to validation discrepancies, deviations, and non-conformances, utilizing structured root cause analysis methodologies to identify corrective actions and prevent recurrence. Partner with project teams during FAT, SAT, commissioning, startup, and qualification activities while maintaining ownership of validation deliverables, change requests, and compliance requirements. Provide leadership for validation workstreams, including project coordination, contractor oversight, schedule management, budget tracking, status reporting, and continuous improvement initiatives. Qualifications: Minimum of 7 years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments, with significant exposure to automated manufacturing systems. Demonstrated expertise authoring and executing validation documentation throughout the equipment and process lifecycle, including IV, OV, PV, commissioning, qualification, and change control activities. Strong background conducting systematic troubleshooting, deviation investigations, and root cause analysis within GMP-regulated operations. Proven project leadership experience with the ability to manage multiple validation projects simultaneously while collaborating effectively with engineering, operations, quality, and manufacturing stakeholders. Bachelor's degree in Engineering, Computer Science, or a related technical discipline; advanced degree preferred. Working knowledge of GAMP 5, 21 CFR Part 11, FDA regulations, ICH guidelines, electronic records systems, and quality management principles is highly desired. Compensation: Salary Range: $160,000 - $170,000 annually Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K Application Details Location: Clayton, NC Work Schedule: 100% Onsite (5 Days per Week) Employment Type: Contract Contract Duration: December 2026 - November 2028 Posting Date: 10.6.26