Validation Engineer, Sterile

Role: Validation Engineer specializing in sterile GMP environments, responsible for validation and qualification of manufacturing and packaging equipment, facilities, utilities, and systems. Objectives include ensuring compliance with cGMP, FDA regulations, and risk-based validation principles through protocol development, execution, and documentation. Responsibilities encompass preparing validation plans and reports, executing FAT/SAT, IQ/OQ, PQ, and requalification activities, supporting commissioning, and maintaining inspection-ready validation records. Collaborates with Engineering, Manufacturing, Quality, vendors, and contractors; supports audits and inspections; manages change controls and CAPAs related to validated systems. Qualifications: Bachelor's degree in Engineering, life sciences, or related field (Master's preferred); 2+ years in validation within GMP-regulated pharma or biotech, with sterile/aseptic experience; knowledge of cGMP, GDP, FDA standards, and validation processes; strong technical writing, data analysis, and cross-functional communication skills. Additional: Physical requirement includes OSHA-compliant respirator fit testing. The position is based in a regulated manufacturing setting, with familiarity in technical drawing review and electronic validation systems.