• Manufacturing Engineer II/III (Process Validation)

    Job Locations US-MA-Bedford
    Posted Date 5 months ago(5 months ago)
    Job ID
    2018-1067
    # of Openings
    1
    Category
    Operations
  • Overview

    The Manufacturing Engineer II/III shall lead technology transfer from product development to plant manufacturing for new product development projects. Supports transfer of clinical manufacturing to plant manufacturing including risk assessment, scale-up, process optimization, and process validation. The position is the technical lead within the manufacturing organization for process knowledge and understanding of 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 new 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
    • Revise batch records and standard operating procedures.
    • Author User Requirement Specifications for large capital custom automated equipment.
    • Manufacturing technical lead for commercial production
    • Write and execute 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 FDA regulated industry, preferably pharmaceuticals.
    • Experience with chemical processing equipment and manufacturing unit operations, preferably including lyophilization development and/or microparticle processing
    • Experience in process development and process validation
    • Strong technical writing and data analysis skills
    • In-depth knowledge of Good Documentation Practices and Good Manufacturing Practices.
    • 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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