Intern, Engineer
ADMA Biologics, Inc.
Full-time
Remote friendly (Boca Raton, FL)
United States
Operations
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Role Summary
Intern, Engineer at ADMA Biologics. The Engineer Intern will provide process development and transfer support for IgG immunotherapy production, maintain PD laboratory compliance, and execute process development studies and 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 and 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.
- 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.
- Transfer process changes and/or new processes from PD to Manufacturing.
- Act as a liaison between PD and Manufacturing for supporting deviations and investigations and transferring new/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 with development and implementation of new process/technology.
- Assist manufacturing personnel in executing process development and process validation studies in a cGMP production environment as necessary.
Qualifications
- Experience Requirements: Currently enrolled in or recent graduate of a relevant degree program (e.g., Engineering).
- Competencies: Ability to read and understand blueprints; able to work in a high-pressure, deadline-driven environment; basic computer skills.
Skills
- Process development and transfer
- cGMP documentation and compliance
- Experiment design and data interpretation
Education
- Relevant engineering or related degree program (pursuing or recent graduate).
Additional Requirements
- None specified beyond listed qualifications.