Essential Functions:

- Operate autoclave equipment and associated sterilization apparatus in compliance with established SOPs and GMP requirements
- Support sterilization cycle operations including loading, unloading, and monitoring of autoclave processes to meet product specifications
- Perform general maintenance on autoclave equipment and associated apparatus as required to ensure operational readiness
- Execute standard operating procedures to meet current Good Manufacturing Practices (cGMP) requirements for sterile manufacturing
- Maintain accurate batch documentation records in compliance with regulatory and internal requirements
- Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines
- Participate in process improvement projects to enhance quality, cost efficiency, and production scheduling
- Conduct area cleaning and sanitization activities in accordance with cleanroom and aseptic GMP standards.
- Responsible for operation and cleaning of energetic pass box in autoclave area.

- To carry out CIP & SIP of the vessels related to autoclave area.
- Responsible for operation and cleaning of area equipment present in the autoclave area like Pass boxes,





Glove cleaning and integrity testers.

- Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the

production area.

- Operation and cleaning of table mounted LAF and Ceiling mounted LAF and steam sterilizer and HPHV

steam sterilizer.

- Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and

seals for sterilization as per the validated load pattern.

- Responsible for Maintenance and cleaning of Component preparation and sterilization area (Autoclave

area).

- Cleaning and sanitization of drain points in Component preparation and sterilization area (Autoclave

area).

- Monitoring of DP, RH and temperature in compounding and filtration area, autoclave area.
- Responsible for timely completion of calibrations and validations activity in coordination with Engineering

and QA related to autoclave area.

Education:

- Bachelors Degree (BA/BS) B. Sc. - Required

- Master Degree (MS/MA) M. Sc.. - Preferred

Experience:

- 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

📌 Executive, autoclave (India)
🏢 Amneal Pharmaceuticals
📍 India