Position Description

Senior Process Engineer
Location Lexington, MA
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Scope: 

Working at the direction of the Manufacturing Engineering team lead, supports setting up a GMP compliant clinical manufacturing facility.  Assists with manufacturing engineering, process scale-up and problem solving with regards to equipment and systems.  Collaborates with and supports Facilities, Process Development, Quality, Supply Chain groups.

 

Responsibilities:

May include some or all of the following:

  • Provide Engineering support to GMP manufacturing.
  • Responsible for troubleshooting and preventative maintaining the GMP equipment.
  • Lead the equipment design changes, change controls, CAPAs.
  • Work with external partners and vendors for developing specifications for equipment, instruments, and materials of construction.
  • Support process validation efforts.
  • Develop material balance and active process engineering based on materials flow.
  • Develop P&IDs to the process specifications.
  • Perform process scale up with input from Process Development and the Manufacturing teams.
  • Effectively collaborate with other team members, including engineers, chemists, quality specialists, and technicians for GMP plant operations.
  • Ensures regulatory, GMP standards and internal quality compliance for all project work.
  • Maintain a safety-first approach to manufacturing and support the in-house EHS program.

Education / Experience:

  • Bachelors or Master’s in Chemical Engineering with 7 years of experience in GMP/clean room manufacturing environment.
  • Equipment Qualification and Validation IQ/OQ/PQ experience in GMP/clean room environment.

Skills / Pre-requisites:

  • Working knowledge of methods and procedures used in the manufacture and quality control of APIs required.
  • Working experience with API associated equipment and downstream purification equipment (Chromatography, TFF).
  • Working experience with CAD or similar P&ID developing tools.
  • Must be highly motivated with good organizational and analytical/technical problem solving skills 
  • Must be a self-starter with capability of working under minimal supervision and work well in a team based environment
  • Have effective written and oral communication skills
  • Computer skills in Microsoft Office suite including Project and Visio
  • Design of Experiments (DOE)
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