Production Sterile - Autoclave - Junior Operator

USV PRIVATE LIMITED; Daman; On-site; INR 300,000 - 600,000; Full time

Job summary

USV PRIVATE LIMITED in India seeks a sterile manufacturing professional to operate autoclaves and manage loading patterns within a cleanroom, ensuring compliant batch processing.

You will execute sterilization cycles (gravity, prevacuum, air-overpressure) using PLC/SCADA, monitor critical parameters, and document BMR data. Adherence to ALCOA+ and safety protocols is required, with ED/line clearance and aseptic transfer responsibilities.

Qualifications

• Experience operating autoclaves in controlled cleanroom environments.
• Familiar with gravity and prevacuum sterilization cycles.
• Knowledge of ALCOA+ data integrity principles.
• Strong safety and PPE compliance.

Responsibilities

• Prepare, load, and run autoclave cycles per validated loading patterns.
• Monitor chamber temperature, time, and pressure during cycles.
• Log cycle data in Batch Manufacturing Records (BMR).
• Verify indicators (physical, chemical, BIs) for cycle release.
• Perform line clearance and ensure proper aseptic transfer between processes.
• Maintain autoclave logbooks and prepare for audits (USFDA, EU Annex 1).
• Conduct daily/weekly preventive maintenance checks and leak tests.

Skills

Autoclave operation

Sterilization cycles

ALCOA+ documentation

Safety compliance

Tools

PLC/SCADA

Job description

• Autoclave Setup & Loading: Prepare, assemble, and load terminal steam sterilizers (autoclaves) with cleanroom garments, equipment parts, tubing, and filling line change parts per validated loading patterns.
• Cycle Execution & Control: Operate moist heat sterilization cycles (gravity, prevacuum, air-overpressure) using automated PLC/SCADA terminals following validated recipe parameters.
• In-Process Cycle Monitoring: Monitor critical sterilization parameters, including chamber temperature, exposure time, F0 values, pressure differential, and vacuum hold performance.
• Sterility Assurance & Indicators: Place and verify physical, chemical, and Biological Indicators (BIs) across loads to validate cycle efficacy and release sterilized components.
• Post-Sterilization Aseptic Transfer: Unload sterilized loads using proper aseptic handling techniques and transfer components into Grade A/B cleanrooms through double-ended pass-through airlocks.
• Line Clearance & Sanitization: Perform line clearance routines, equipment surface sanitization, and chamber cleanings between sterilization runs to prevent cross-contamination.
• Sterilization BMR & Logbook Entries: Log real-time process data, cycle printouts, temperature recorder charts, and equipment status updates in Batch Manufacturing Records (BMR) following ALCOA+ rules.
• Preventive Maintenance & Leak Testing: Perform daily/weekly routine maintenance checks, door gasket inspections, air detector tests, and Bowie-Dick steam penetration tests.
• Audit & Compliance Readiness: Maintain autoclave logbooks, Bowie-Dick test records, and cycle trend graphs in an organized, audit-ready state for regulatory inspections (USFDA, EU Annex 1).
• EHS & Safety Enforcement: Strictly enforce steam plant safety protocols, wear heat-resistant thermal PPE, inspect pressure safety valves, and observe hot-surface safety guidelines.