• Manufacturing Engineer I/II, Validations

    Job Locations US-MA-Bedford
    Posted Date 1 month ago(1 month ago)
    Job ID
    2018-1101
    # of Openings
    1
    Category
    Operations
  • Overview

    The Manufacturing Engineer I/II, Validations shall assist with equipment, utility and facility validations within the organization including commissioning and qualification, and maintenance of the validated state, of all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug substance platforms. 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 execution of validation activities and validation assignments supporting all technical and manufacturing involving the qualification of new and existing facilities, utilities, equipment and/or computerized systems
    •Write, execute, and lead facilities and equipment validations, reviewing and analyzing data, adhering to GMP regulations. Support cross-functional teams to establish site validation master plans, cleaning validation master plans, etc for complex product development projects
    •Incorporating continuous process improvements and policies including functional and user requirement specifications
    •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 support for manufacturing for equipment or facility validations, participating in regulatory inspections
    •Write and execute test protocols for trials of new materials, equipment, tooling, etc.

    Qualifications

    •Bachelor's Degree in Engineering, preferably Chemical
    •Minimum of 2 years’ experience in validations, in the pharmaceutical or medical device industry 
    •Ability to work with people at all levels
    •Must be proficient with Microsoft Office, particularly Word and Excel
    •This position requires mobility and some physical ability to set up and work with equipment

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