ADMA BIOMANUFACTURING LLC
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 aProcess 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.
TheProcess Engineer I will:
Education Requirements:
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 visit
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 aProcess 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.
TheProcess 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.
Education Requirements:
- Bachelor's degree in Science or Engineering.
- 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.
- 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 visit
ADMA Biologicsis an Equal Opportunity Employer.