Senior Validation Engineer

Responsibilities: Lead commissioning, qualification, and validation activities for manufacturing equipment, production lines, and facility systems supporting pharmaceutical operations. Develop and execute lifecycle validation documentation including validation strategies, risk assessments, protocols, traceability documentation, and final summary reports. Support multiple concurrent capital and operational projects involving packaging equipment, device assembly systems, sterile filling processes, utilities, facilities, and production infrastructure. Investigate validation-related deviations, assess the impact of engineering changes, and support change control activities while ensuring regulatory compliance. Partner with project managers, engineering teams, vendors, and operations personnel to provide project updates, coordinate validation activities, and meet demanding implementation timelines. Qualifications: 5-10 years of hands-on manufacturing validation experience within regulated pharmaceutical or biotechnology environments, with a strong preference for packaging, fill-finish, or device assembly operations. Demonstrated expertise authoring and executing IQ, OQ, PQ, process validation, commissioning, and qualification documentation for GMP manufacturing systems. Proven ability to work independently, manage priorities across multiple projects, and deliver results with minimal supervision. Working knowledge of FDA regulations, GMP requirements, GAMP principles, Annex 15 guidance, and validation lifecycle methodologies. Experience supporting equipment upgrades, production line modifications, automated manufacturing systems, and electronic quality documentation platforms. Compensation: Salary Range: $140,000 - $165,000 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: 24-Month Contract Contract Duration: Approximately December 2026 through November 2028 Posting Date: 10.6.26