About the role
Aseptic Operator (Sterile Production): Key Responsibilities Aseptic Filling: Operate high-precision filling and sealing machines for vials, ampoules, or pre-filled syringes in Grade A/B environments. Sterile Setup: Perform aseptic assembly of machine parts and sterilized components (tubing, needles, pumps) using "no-touch" techniques. Environmental Monitoring: Strictly maintain cleanroom discipline and assist in monitoring air particulates and microbial plates. Sterilization (Autoclave/SIP): Execute and monitor sterilization cycles for equipment (SIP) and materials (Autoclave) to ensure sterility. Gowning & Hygiene: Adhere to the highest standards of sterile gowning and maintain slow, deliberate movements to prevent air turbulence. Documentation: Precisely record batch data in BMRs and maintain logs for sterilization, filter integrity tests (Bubble Point), and leak tests.