Process Engineer (OSD)
8 days ago
Job Number
30994
Country of work
Taiwan
Region
N/A
Position
Process Engineer (OSD)
Minimum Education
N/A
To fill by
N/A
Salary
No salary listed
Number of vacancies
1
Specialty
PHARMACEUTICAL
Job Description
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Visit TodayThis position will provide support and assistance in the manufacture of pharmaceutical products for commercial and clinical supplies. Key duties include scale-up and transfer of oral solid dosage formulations/processes to production facility, design and recommend equipment purchases, write and execute equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes.
Knowledge/Skills Needed:
- Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.
- Thorough knowledge of automated control systems.
- Thorough knowledge of computer systems operation and software.
- Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
- Knowledge of chemistry, statistics, equipment design, process control and process scale-up.
- Knowledge of oral solid dose pharmaceutical operations preferred and equipment validations.
- "Hands-on" ability to install and troubleshoot instrumentation and equipment.
- Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
- Ability to author high quality technical protocols/reports (Engineering Studies, commissioning protocols, summary reports, equipment specifications, SOPs, deviation investigations).
- Ability to specify and size manufacturing systems, equipment, and process equipment.
- Ability to gown for clean room operations.
- Ability to read, understand and accurately follow company SOPs and guidelines.
Personal Attributes Needed:
- Excellent communication and documentation skills.
- Excellent organizational skills.
- Ability to self-manage and prioritize workload.
- Ability to react quickly to understand and solve problems.
- Excellent troubleshooting skills.
- Positive attitude.
