Senior Quality Assurance Validation Specialist

Role: Senior QA Validation Specialist responsible for validating equipment, systems, and processes in compliance with regulatory standards within a biopharma manufacturing setting. Objectives include ensuring manufacturing quality and conformance, supporting validation activities, and maintaining GxP compliance. Responsibilities involve developing and executing qualification protocols, analyzing validation data, troubleshooting validation issues, reviewing validation documentation, and performing cold-chain shipping and environmental testing, including temperature mapping and vibration/shock profiling. Qualifications: B.S. in life sciences or related field; 4+ years (specialist) or 6+ years (senior) validation experience, with demonstrated expertise in validation methodologies, regulatory compliance, and biopharma manufacturing standards. Preferred skills include experience with ASTM/ISTA cold-chain standards, cleanroom gowning, and equipment qualification. High-Value: Biologics or pharma manufacturing, validation/qualification, GxP, cold-chain logistics, environmental testing, regulated environment, on-site in Rensselaer, NY, with potential for professional growth and development.