Production Sterile - Aseptic - Operator

USV PRIVATE LIMITED; Daman; On-site; INR 250,000 - 450,000; Full time

Job summary

USV PRIVATE LIMITED is seeking an Aseptic Operator for sterile production. The role involves operating high-precision filling machinery for vials, ampoules, or pre-filled syringes within Grade A/B cleanrooms, and performing aseptic assembly with no-touch techniques.

You will help maintain sterile conditions and document batch data. The position requires strict gowning discipline, routine environmental monitoring, and experience with sterilization cycles (Autoclave/SIP) to ensure product

Qualifications

• Experience in aseptic filling in Grade A/B environments.
• Strong understanding of cleanroom procedures and no-touch techniques.
• Experience with environmental monitoring and sterile testing procedures.

Responsibilities

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

Skills

Aseptic filling

Sterile setup

Environmental monitoring

Sterilization (Autoclave/SIP)

Gowning & hygiene

Documentation

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.