Production Sterile - Aseptic - Sr. Operator

USV PRIVATE LIMITED; Daman; On-site; INR 350,000 - 520,000; Full time

Job summary

USV PRIVATE LIMITED seeks an Aseptic Operator (Sterile Production) to operate precision filling and sealing lines for vials, ampoules, or pre-filled syringes in Grade A/B rooms.

You will maintain aseptic assembly, follow no-touch protocols, monitor cleanroom conditions, execute sterilization cycles, uphold gowning standards, and meticulously document batch data in BMRs and related logs for sterilization and integrity tests.

Qualifications

• Aseptic technique demonstrated in sterile production settings.
• Experience with Grade A/B cleanrooms preferred.

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 environmental monitoring of air particulates and microbial plates.
• Execute and monitor sterilization cycles for equipment (SIP) and materials (Autoclave) to ensure sterility.
• Adhere to sterile gowning standards and minimize air turbulence during operations.
• Record batch data in BMRs and logs for sterilization, filter integrity tests (Bubble Point), and leak tests.

Skills

Aseptic technique

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.