Intern, Engineer
ADMA Biologics, Inc.
Full-time
On-site
Boca Raton, FL
Operations
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Role Summary
The Engineer Intern will provide process development and transfer support for IgG immunotherapy production. They will provide updates to the Process Development Management team to ensure compliance, maintain compliance in the PD laboratory, and execute process development/evaluation studies as well as process validations using a scale-down model.
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
- Required: Currently enrolled in or recent graduate of a relevant degree program (e.g., Engineering)
Skills
- Ability to read and understand blueprints
- Able to work in high-pressure, deadline-driven environment
- Basic computer skills
Education
- Engineering or related field (current student or recent graduate)