ADMA BIOMANUFACTURING LLC
Process Engineer I, Process Development
ADMA BIOMANUFACTURING LLC, Boca Raton, Florida, us, 33481
Job Details
Level Experienced
Job Location ADMA Biologics FL - Boca Raton, FL
Position Type Full Time
Education Level 4 Year Degree
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 thebiopharmaceutical industry that is committed toexcellence andintegrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Process Engineer I located in Boca Raton, FL!
The
Process Engineer I will provide process development and Transfer support 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, andRegulatory departments.
The Process Engineer I will: 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. Participate in designing and planning scientific experiments to achieve corporate goals for existing projects. 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. Qualifications
Education Requirements:
Bachelor's degree in Science or Engineering. Experience Requirements:
At least three (3) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment, familiarity with many aspects of process development is expected. Knowledge of FDA cGMP requirements is an essential pre-requisite for this position. In addition to competitive compensation, we offer a comprehensivebenefits 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, Inc.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 visitwww.dhs.gov/E-Verify.
ADMA Biologicsis an Equal Opportunity Employer.
Level Experienced
Job Location ADMA Biologics FL - Boca Raton, FL
Position Type Full Time
Education Level 4 Year Degree
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 thebiopharmaceutical industry that is committed toexcellence andintegrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Process Engineer I located in Boca Raton, FL!
The
Process Engineer I will provide process development and Transfer support 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, andRegulatory departments.
The Process Engineer I will: 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. Participate in designing and planning scientific experiments to achieve corporate goals for existing projects. 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. Qualifications
Education Requirements:
Bachelor's degree in Science or Engineering. Experience Requirements:
At least three (3) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment, familiarity with many aspects of process development is expected. Knowledge of FDA cGMP requirements is an essential pre-requisite for this position. In addition to competitive compensation, we offer a comprehensivebenefits 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, Inc.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 visitwww.dhs.gov/E-Verify.
ADMA Biologicsis an Equal Opportunity Employer.