Senior Operations Technician

Role: Hands-on technician supporting GMP sterile formulation and clinical supply manufacturing in a biopharma setting, specifically in filling, lyophilization, and capping. Responsibilities: perform sterile filling operations, equipment setup, changeovers, adjustments, environmental sampling, and documentation; support equipment commissioning, qualification, and process troubleshooting; collaborate with formulation, engineering, quality, and safety teams to ensure GMP compliance and process improvements. Requirements: High School diploma or Associate degree; minimum 2 years' experience in manufacturing, military, or industrial environments involving complex equipment; proficiency with automated systems, HMI, SAP, and calibration databases; ability to lift 50 lbs, work in cleanroom gowning, and perform physical tasks. Preferred: experience in regulated biopharma manufacturing, aseptic processing, automated equipment, sterile operations, and knowledge of FDA or cGMP standards; technical certifications or bioWork certification are advantageous. HighValue: sterile drug product manufacturing, GMP compliance, automated filling/lyophilization/capping, aseptic processing, working in Grade C cleanroom, equipment troubleshooting, environmental monitoring, and collaboration across manufacturing, quality, and engineering functions. WorkSetup: 100% on-site in Rahway, NJ; overtime expected.