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    Process Engineer II, Process Development - Boca Raton, United States - ADMA BIOMANUFACTURING LLC

    ADMA BIOMANUFACTURING LLC
    ADMA BIOMANUFACTURING LLC Boca Raton, United States

    2 weeks ago

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    Description
    Job Details

    Job Location
    ADMA Biologics - Boca Raton, FL

    Position Type
    Full Time

    Description

    ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Process Engineer II in Boca Raton, Florida.

    The Process Engineer II provides process development and transfer expertise for IgG Immunotherapy Production. Provide updates to Process Development (PD) Management team on a regular basis to ensure compliance issues are being met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model. As a key member of the PD group, provide support for Manufacturing, Quality Control/Quality Assurance, and Regulatory departments.

    Qualifications
    • Provide support for technical issues related to the manufacturing process and product quality.
    • Develop new processes as required for production of plasma derived therapies.
    • Be familiar with regulatory guidelines to process development/validation as well as implementing manufacturing process changes.
    • Optimize and maintain compliance in PD laboratory by ensuring all equipment calibration/IQ/OQ/PM status are current.
    • Design and plan scientific experiments to achieve corporate goals for existing projects. Write protocols and reports in support of PD studies.
    • Review and/or approve cGMP documentation generated by other PD group members as necessary.
    • Lead execution of process development/evaluation studies as well as process validations using a qualified scale down model.
    • Be responsible for transferring process changes and/or new processes from PD to Manufacturing.
    • Act as a liaison between PD and Manufacturing for supporting deviations and investigations as well as when transferring new and/or optimized processes.
    • Maintain and review process development Batch Records for scale down process models.
    • Perform other activities as assigned by the PD Managers.
    • Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
    • Assist manufacturing personnel in the execution of process development and process validation studies in cGMP production environment as necessary.
    Education Requirements:
    • Bachelor's degree in Science or Engineering required.
    Experience Requirements:
    • A minimum of five (5) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment is required.
    • Familiarity with many aspects of process development is expected.
    • Knowledge of FDA cGMP requirements is required.
    In addition to competitive compensation, we offer a comprehensive benefits package including:
    • 401K plan with employer match and immediate vesting
    • Medical, Vision, Life and Dental Insurance
    • Pet Insurance
    • Company paid STD and LTD
    • Company Paid Holidays
    • 3 Weeks' Paid Time Off (within the first year)
    • Tuition Assistance (after the first year)
    • Easily accessible to Tri-Rail
    • Free shuttle to the Boca Tri-Rail station
    ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit

    ADMA Biologics is an Equal Opportunity Employer.
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