Process Scientist/Engineer

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.

Qualifications:  

  • 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.