Sterilization Worker (Pharmaceutical Manufacturing)
めっきんこう
Industry & Occupation
Classification
Summary
A profession that performs sterilization operations in pharmaceutical manufacturing processes to keep products, containers, and equipment in a sterile state, maintaining quality and safety.
Description
Sterilization workers ensure the sterility of pharmaceuticals by processing equipment, containers, and formulations using various sterilization technologies, including autoclaves, sterile filtration, chemical sterilization (such as ethylene oxide), and radiation sterilization. Work is conducted in clean rooms, complying with SOPs (Standard Operating Procedures) based on GMP (Good Manufacturing Practice). They ensure process integrity through condition setting, equipment operation, process monitoring, validation testing, and record management. In the event of nonconformities, they perform root cause analysis and implement recurrence prevention measures.
Future Outlook
With the strengthening of pharmaceutical quality regulations and the expansion of biopharmaceuticals, demand for specialized personnel in sterilization processes is expected to remain stable. In particular, those proficient in validation and aseptic formulation technologies will continue to see high demand.
Personality Traits
Cautious and precise / High concentration / Strong sense of responsibility
Work Style
Career Path
Sterilization Operator → Senior Sterilization Staff → Validation Engineer → Manufacturing Supervisor (GMP Leader) → Manufacturing Department Manager
Required Skills
Autoclave Operation / Bioburden Measurement / Clean Room Work / Document Record Management / GMP Knowledge / Sterile Filtration Technology / Sterilization Validation
Recommended Skills
Ethylene Oxide Gas Sterilization / Gamma Ray Sterilization Process / Reading English Technical Documents / Statistical Quality Control
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Attention to Detail & Accuracy | Because even slight deviations in sterilization conditions directly impact product safety. |
Related Qualifications
- Hazardous Materials Handler (Class B, Category 4)
Aliases
- Sterilization Operator
Related Jobs
- Filling Worker
- Formulation Worker
- GMP Auditor
- Quality Control Inspector