Job Description

Production Sterile: Autoclave – Officer

Sterilization Operations Supervision: Direct and supervise daily moist-heat sterilization cycles (autoclaves) and dry-heat sterilization/depyrogenation tunnels for equipment parts, garments, tubing, and glass containers.
Sterilization Recipe & Cycle Management: Program, verify, and monitor validated sterilization cycles (gravity, prevacuum, air-overpressure), ensuring critical parameters ( $F_0$ values, dwell time, temperature, and pressure) are consistently met.
Aseptic Load Transfer Oversight: Enforce strict aseptic unload protocols for transferring sterilized items from double-door autoclaves directly into Grade A/B cleanroom processing cores.
BMR & Sterilization Log Verification: Execute and review real-time Batch Manufacturing Records (BMR), autoclave cycle printouts, temperature/pressure recorder charts, and equipment logbooks adhering to ALCOA+ data integrity standards.
Sterility Assurance & Indicator Testing: Coordinate physical, chemical, and Biological Indicator (BI) placement and retrieval for load release, managing incubation tracking alongside Quality Control (QC).
Equipment Qualification & Thermal Mapping: Coordinate quarterly and annual re-qualification activities, including thermal mapping, heat distribution/penetration studies, and Bowie-Dick steam penetration testing with Validation and Engineering teams.
Line Clearance & Sanitization Enforcement: Perform and sign off on Type A/B line clearances, equipment surface sanitization, and chamber leak testing prior to initiating sterilization runs.
QMS Investigation & RCA Lead: Initiate and lead shop-floor QMS tasks, investigating autoclave cycle deviations, sterilization failures, $F_0$ non-conformances, and implementing assigned CAPA measures.
Audit Representation (EU Annex 1): Act as the front-line Subject Matter Expert (SME) during internal and regulatory audits ( USFDA, EU Annex 1, WHO ), presenting sterilization logs, load patterns, and BI challenge records.
EHS & Pressure Vessel Safety: Enforce steam plant safety protocols, monitor pressure safety valve calibrations, ensure proper thermal PPE usage, and maintain workplace 5S discipline across the sterilization area.