Process Engineer II, Process Development

3 weeks ago

Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time
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 www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.

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