About The Role

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 dynamic 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.