Engineer Process I

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

Benefits

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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