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Process Engineer (OSD)
8 days ago
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Process Engineer (OSD)
Minimum Education
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Job Description

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This 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.