Executive, autoclave

Amneal Pharmaceuticals; Hyderabad; On-site; INR 250,000 - 450,000; Full time

Job summary

Amneal Pharmaceuticals in Hyderabad, India seeks an experienced Sterilization Operator to manage autoclave operations within sterile manufacturing. You will ensure SOP and cGMP adherence, maintain batch records, and support calibration and validation activities.

The role requires 2+ years in a sterile environment, with Bachelor's degree in a relevant field; a Master’s degree is a plus. Join a regulated production team focused on quality and efficiency.

Qualifications

• Bachelor's degree in a relevant science or engineering field is required.
• Master's degree is preferred.
• 2+ years of experience in sterile manufacturing or related field.

Responsibilities

• 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 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.

Skills

Autoclave operation

GMP compliance

cGMP documentation

Education

Bachelor's Degree (BA/BS)

Master's Degree (MS/MA)

Tools

Autoclave equipment

LAF systems

CIP/SIP processes

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,

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: