ADMA Biologics, Inc.
Process Engineer I – Boca Raton, FL
Join ADMA Biologics, Inc. to lead process development and transfer support for IgG Immunotherapy Production. The Process Engineer I will provide process development and transfer support for IgG Immunotherapy Production, maintaining compliance and executing process development/evaluation studies and process validations using a scale‑down model.
The role supports manufacturing, quality control/quality assurance, and regulatory departments. Responsibilities
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 the 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 a cGMP production environment as necessary. Qualifications
Bachelor’s degree in Science or Engineering. At least three (3) years of experience in a cGMP, pharmaceutical/biological manufacturing environment, with familiarity with many aspects of process development. Knowledge of FDA cGMP requirements. Benefits
401(k) plan with employer match and immediate vesting. Medical, vision, life, and dental insurance. Pet insurance. Company‑paid short‑term and long‑term disability. Company‑paid holidays. 3 weeks’ paid time off in the first year. Tuition assistance after the first year. Easy access to Tri‑Rail and free shuttle to the Boca Tri‑Rail station. EEO Statement
ADMA Biologics, Inc. uses E‑Verify to confirm the employment eligibility of all newly hired employees. ADMA Biologics is an Equal Opportunity Employer.
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Join ADMA Biologics, Inc. to lead process development and transfer support for IgG Immunotherapy Production. The Process Engineer I will provide process development and transfer support for IgG Immunotherapy Production, maintaining compliance and executing process development/evaluation studies and process validations using a scale‑down model.
The role supports manufacturing, quality control/quality assurance, and regulatory departments. Responsibilities
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 the 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 a cGMP production environment as necessary. Qualifications
Bachelor’s degree in Science or Engineering. At least three (3) years of experience in a cGMP, pharmaceutical/biological manufacturing environment, with familiarity with many aspects of process development. Knowledge of FDA cGMP requirements. Benefits
401(k) plan with employer match and immediate vesting. Medical, vision, life, and dental insurance. Pet insurance. Company‑paid short‑term and long‑term disability. Company‑paid holidays. 3 weeks’ paid time off in the first year. Tuition assistance after the first year. Easy access to Tri‑Rail and free shuttle to the Boca Tri‑Rail station. EEO Statement
ADMA Biologics, Inc. uses E‑Verify to confirm the employment eligibility of all newly hired employees. ADMA Biologics is an Equal Opportunity Employer.
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