Sr Engineer, Validation

Role: Senior Validation Engineer ensuring compliance with cGMP regulations through validation activities across GMP manufacturing environments. Responsibilities: lead development and execution of commissioning, qualification (CX/IQ/OQ/PQ), and validation protocols for equipment, systems, and facilities; review technical documentation; perform process validations such as sterilization and aseptic processing; manage validation projects, support regulatory inspections, and serve as SME across validation disciplines (e.g., computer systems, laboratory systems, risk management). Requirements: BS in Engineering, Chemistry, Microbiology, or related field; minimum 8 years’ experience in validation within biopharma or GMP manufacturing; expert knowledge of validation principles, GxP regulations (ISPE, CFR 210/211, Part 11), and systems such as CIP, SIP, autoclaves, critical utilities. Skills: strong technical, communication, and project management capabilities; proficient in validation software (e.g., Kaye AVS), reading P&IDs, schematics; ability to operate independently in a fast-paced environment. Preferred: experience with biopharmaceutical systems, regulatory agency interactions. High-Value: validation leadership in sterile or aseptic manufacturing, process validation expertise, regulatory compliance within biopharma. Work setup: not specified; likely on-site with potential for minimal travel.