• Manufacturing Engineer I, Process Validation

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(10/4/2018 12:17 PM)
    Job ID
    2018-1115
    # of Openings
    1
    Category
    Operations
  • Overview

    The Manufacturing Engineer I, Process Validation shall assist with diverse commercial product and new product development projects in the manufacturing organization, and all facility related engineering projects and ongoing maintenance. Assists with transfer of clinical manufacturing to Technical Operations 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

    • Assist in the development and implementation of manufacturing processes for complex product development projects
    • Technical Operations Engineering representative for the transfer of manufacturing for late stage development projects including evaluation of processes to improve COGs and efficiency
    • Assist with the specification and sourcing of process equipment, fixtures, packaging materials, and other equipment and materials to support manufacturing and product development for expansion and commercialization including high capital automation
    • Assist with 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 1 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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