Pharmaceutical Manufacturing Engineer (Excluding Production Engineers)
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
Specialist who operates and manages pharmaceutical manufacturing processes to ensure quality and safety.
Description
Pharmaceutical manufacturing engineers execute and manage a series of manufacturing processes—such as raw material preparation, reaction and separation processes, formulation, filling, and packaging—based on GMP standards. They perform aseptic operations in clean rooms, quality control tests, creation and storage of batch records, and simple maintenance of manufacturing equipment. When issues arise, they conduct troubleshooting of the manufacturing line and root cause analysis. They are required to have a high level of hygiene management awareness and strict adherence to precise work procedures, contributing to the safe and stable operation of pharmaceutical factories.
Future Outlook
Demand is expected to remain stable due to the aging society and expansion of biopharmaceuticals. As smart factories utilizing automation and AI advance, acquisition of advanced digital skills will be required.
Personality Traits
Cautious / Cooperative / Hygiene Conscious / Strong Sense of Responsibility
Work Style
Career Path
Manufacturing Operator → Line Leader → Manufacturing Manager → Quality Assurance Manager → Factory Manager
Required Skills
Aseptic Operations / Basic Operation of Analytical Instruments / Batch Record Management / Clean Room Work Procedures / GMP Standards
Recommended Skills
Lean Production Methods / Reading English Literature / Statistical Process Control / Validation Techniques
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Analytical & Logical Thinking | The ability to scientifically evaluate the effects of raw materials and process parameters and optimize them is essential. |
| Attention to Detail & Accuracy | Even minor procedural errors are not tolerated to ensure GMP compliance. |
| Problem Solving | Troubleshooting manufacturing lines and identifying causes of defects are required. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Creativity & Ideation | Routine tasks predominate, with emphasis placed on standards compliance rather than new ideas. |
Related Qualifications
- GMP Training Completion Certificate
- Hazardous Materials Handler (Class B, Type 4)
- Quality Management Certification
Aliases
- Pharmaceutical Manufacturing Engineer
- Pharmaceutical Process Engineer
Related Jobs
- Formulation Development Engineer
- Pharmaceutical Manufacturing Operator
- Quality Control Engineer