Production - Operator / Supervisor

Bharat Biotech International; Hyderabad; On-site; INR 300,000 - 460,000; Full time

Job summary

Bharat Biotech International in Hyderabad, India, seeks a role focused on sterilization operations and autoclave validation in a GMP environment.

You will operate steam sterilizers and HPHV autoclaves, monitor process parameters, prepare loads, and maintain BMRs and logs to regulatory standards.

Candidates with vaccine manufacturing experience are preferred; the role requires meticulous documentation and routine autoclave upkeep.

Responsibilities

• Operate steam sterilizers, HPHV autoclaves, dynamic pass boxes, and laminar air flow (LAF) units according to validated cycle parameters.
• Monitor and record critical process parameters including temperature, pressure, time, differential pressure (DP), and relative humidity (RH).
• Arrange and load materials, filling machine accessories, change parts, garments, and stoppers per validated load patterns.
• Maintain accurate Batch Manufacturing Records (BMRs), equipment logbooks, and sterilization logs compliant with FDA, EMA, and cGMP standards.
• Conduct routine cleaning, disinfection, and minor maintenance of autoclave chambers, preparation areas, and auxiliary.
• VLT Test (0.013 bar) and Bowdik Test (KIT).
• Autoclave Validation
• HPHV1, HPHV2, HPHV3

Job description

Role & responsibilities

• Equipment Operation: Operate steam sterilizers, HPHV autoclaves, dynamic pass boxes, and laminar air flow (LAF) units according to validated cycle parameters.
• Cycle Monitoring: Monitor and record critical process parameters including temperature, pressure, time, differential pressure (DP), and relative humidity (RH).
• Load Preparation: Arrange and load materials, filling machine accessories, change parts, garments, and stoppers per validated load patterns.
• Documentation & Compliance: Maintain accurate Batch Manufacturing Records (BMRs), equipment logbooks, and sterilization logs compliant with FDA, EMA, and cGMP standards.
• Sanitization & Maintenance: Conduct routine cleaning, disinfection, and minor maintenance of autoclave chambers, preparation areas, and auxiliary.
• VLT Test (0.013 bar) and Bowdik Test (KIT).
• Autoclave Validation
• HPHV1, HPHV2, HPHV3

Preferred candidate profile

Candidates having Vaccine experience will be preferred