Production Sterile - Aseptic - Operator

USV; Daman; On-site; INR 320,000 - 520,000; Full time

Job summary

USV is seeking an Aseptic Operator (Sterile Production) to operate high-precision filling and sealing machines in Grade A/B cleanrooms, ensuring strict aseptic conditions.

You will perform sterile setup, environmental monitoring, autoclave/SIP sterilization, gowning, and meticulous documentation in BMRs and test logs to maintain batch sterility. The role requires disciplined, steady movements to minimize air turbulence and strict adherence to GMP standards.

Responsibilities

• Operate high-precision filling and sealing machines for vials, ampoules, or pre-filled syringes in Grade A/B cleanrooms.
• Perform aseptic assembly of machine parts and sterilized components using no-touch techniques.
• Maintain cleanroom discipline and assist in environmental monitoring of air particulates and microbial samples.
• Execute and monitor sterilization cycles (Autoclave/SIP) to ensure sterility.
• Record batch data in BMRs and maintain logs for sterilization, filter integrity tests, and leak tests.
• Adhere to gowning and hygiene standards to prevent air turbulence.

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.