Production Sterile - Aseptic - Sr. Operator
Job Description
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.