Pharmaceutical Manufacturing Engineer
いやくひんせいぞうぎじゅつしゃ
Industry & Occupation
Classification
- Major : Research and Technical Occupations
- Middle : Manufacturing Engineers
- Minor : Chemical Product Manufacturing Engineers
Summary
A specialist who manages and operates the pharmaceutical manufacturing process from raw material blending to formulation, filling and packaging, ensuring safety and quality.
Description
Pharmaceutical manufacturing engineers handle the entire manufacturing process from raw material weighing and preparation, chemical reactions, separation and purification processes, formulation (tablets, capsules, injections, etc.), to aseptic filling and packaging. They perform equipment operation, clean room management, and in-process quality control (intermediate inspections) based on standard operating procedures (SOP) and validation documents. Through creating manufacturing records, handling deviations, and collaborating with other departments (quality assurance, maintenance, process development), they supply products while complying with legal regulations (GMP/GQP) and safety standards.
Future Outlook
Amid strengthening quality regulations and the introduction of production automation and continuous production systems, demand for manufacturing engineers with advanced process development and improvement capabilities and data utilization skills is expected to increase.
Personality Traits
Cautious and accurate / Cooperative / Eager to improve / Strong sense of responsibility
Work Style
Clean Room Work / Day Shift System / Factory Work / Pharmaceutical Manufacturer / Shift Work
Career Path
Manufacturing Operator → Senior Manufacturing Engineer → Manufacturing Supervisor (Line Leader) → Production Technology and Process Development → Quality Assurance (QA)
Required Skills
Basic Operation of Analytical Instruments / Clean Room Manufacturing / GMP Knowledge / Manufacturing Equipment Operation / SOP Operation
Recommended Skills
Aseptic Techniques / Data Analysis / Reading English Technical Documents / Validation and Calibration
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Attention to Detail & Accuracy | Even minor procedural errors or record deficiencies can lead to quality incidents. |
| Learning Agility & Knowledge Acquisition | Adaptation to new formulation technologies and regulatory revisions is necessary. |
| Problem Solving | Quick identification of causes and countermeasures are required for deviations or equipment troubles during manufacturing. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Creativity & Ideation | Routine tasks predominate, and adherence to procedures is more important than creative ideas. |
Related Qualifications
- Hazardous Materials Handler Class B Type 4
- Pharmaceutical Manufacturing Operations Supervisor
- Poisonous and Deleterious Substances Handler Supervisor
Aliases
- Formulation Technician
- Pharmaceutical Manufacturing Operator
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