Executive, autoclave

Essential Functions

JOB DESCRIPTION

• 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.

Education

QUALIFICATIONS

• 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: