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Process Engineer - Active Pharmaceutical Ingredients

Boston, MA, United States

Posted on
Aug 14,2019

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Our client is a highly regarded manufacturer of Active Pharmaceutical Ingredients (API) and a Contract Development and Manufacturing Organization (CDMO) in need of an experienced Process Engineer to oversee development of processing instructions for manufacturing and the introduction of new materials to the plant environment.nnRESPONSIBILITIESnn* Lead project start-ups, process optimization and trouble shooting for the manufacture of all APIs.nn* Manage production processes to comply with all applicable standards and regulations including, cGMP, PSM, and FDA regulations.nn* Create and manage Master Batch Records and Batch Production records.nn* Train Production operators on all new production processes and procedures.nn* Lead efforts to optimize production processes by reducing cycle times, improving batch yields, improving quality and reducing manufacturing costs.nn* Collaborate internally with other departments and locations to ensure all customer requirements are efficiently met.nnREQUIREMENTSnn* B.S. degree in Chemical Engineering (highly preferred) or Chemistry.nn* A minimum of 5 years experience as a Process Engineer in API, Fine or Specialty Chemical manufacturing.nn* cGMP experience highly preferred.nn* Previous experience writing Master Batch Records and Batch Production Records.nn* Hands-on manufacturing knowledge of multi-step molecule synthesis with an emphasis on reactions, extractions, distillation, filtration and drying.nn* Technology transfer skills, from lab through scale up to plant.nn* Working knowledge of glass lined and rotating process equipment.nn* Excellent oral and written communication skills.nn* Ability to lead projects and train people.,

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