Process Engineer II, Process Development - Adma Biomanufacturing Llc
Boca Raton, FL 33487
About the Job
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.
