Job Description This position will provide support and assistance in the manufacture of pharmaceutical products for commercial supplies.
Key duties include:
- Scale-up and transfer of Sterile injectable and 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.
- Bachelor's degree; scientific/ engineering or equivalent field.
- Minimum of 2+ years working experience in pharmaceutical engineering, development or equivalent.
Technical Knowledge/Skills Needed:
- Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as aseptic and 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, ISO and FDA facility requirements and regulations.
- Thorough knowledge of chemistry, statistics, equipment design, process control and process scale-up.
- Knowledge of aseptic or oral solid dose pharmaceutical operations 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 and SOPs.
- 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.