Process Engineer II, Process Development

2 weeks ago

Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

Job DetailsJob LocationADMA Biologics - Boca Raton, FLPosition TypeFull TimeDescriptionADMA 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. QualificationsProvide 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 vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA 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 www.dhs.gov/E-Verify.ADMA Biologics is an Equal Opportunity Employer.

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