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    Head of Manufacturing Engineering - Indiana, United States - Catalyst Life Sciences

    Catalyst Life Sciences
    Catalyst Life Sciences Indiana, United States

    3 weeks ago

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    Description


    The client is seeking a Head of Manufacturing Engineering to manage a team of engineers who provide technical support for on-going plant manufacturing operations in the tissue tech Skin product and Medical Product areas.


    Responsibilities:
    Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with procedures and statutory requirements (US FDA and ISO)
    Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device manufacturing
    Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing

    Qualifications:
    8+ years experience in the medical device or pharmaceutical industry
    Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines is required
    Experience managing direct reports (REQUIRED)
    For more information about this or other senior positions please contact Nick Giordano at

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