• Manufacturing Engineer II/III (Process Validation)

    Job Locations US-MA-Bedford
    Posted Date 3 months ago(5/2/2018 8:58 AM)
    Job ID
    2018-1067
    # of Openings
    1
    Category
    Operations
  • Overview

    The Manufacturing Engineer II/III shall lead diverse commercial product and new product development projects in the manufacturing organization, and all facility related engineering projects and ongoing maintenance. Supports transfer of clinical manufacturing to Technical Operations, execution of process validation and provides technical support for process performance. The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks.

     

    Responsibilities

    • Lead the development and implementation of manufacturing processes for complex product development projects
    • Manufacturing lead for the transfer of manufacturing for late stage development projects including evaluation of processes to improve COGs and efficiency
    • Specify and source process equipment, fixtures, packaging materials, and other equipment and materials to support manufacturing and product development for expansion and commercialization including high capital automation
    • Technical lead for manufacturing for commercial production
    • Write, execute, and lead equipment and process validations
    • Write and execute test protocols for trials of new materials, equipment, tooling, etc.

     

    Qualifications

    • Bachelor's Degree in Engineering, preferably Chemical
    • Minimum of 4 years’ experience in manufacturing or product development in the pharmaceutical industry
    • Ability to work with people at all levels
    • Experience in process validation, lyophilization development and/or microparticle processing is preferred
    • Must be proficient with Microsoft Office, particularly Word and Excel
    • Must be able to work in both cleanroom and chemical laboratory environments
    • The position requires mobility and some physical ability to set up and work with equipment

     

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