Process Engineer II, Process Development

Process Engineer II, Process Development - Boca Raton, FL

The Process Engineer II provides process development and transfer expertise for IgG Immunotherapy Production. Provides updates to PD Management team on a regular basis to ensure compliance issues are met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model. As a key member of the PD group, supports Manufacturing, QC/QA, and Regulatory departments.

• Provide support for technical issues related to the manufacturing process and product quality.
• Develop new processes for production of plasma-derived therapies.
• Be familiar with regulatory guidelines regarding process development/validation and implementing manufacturing process changes.
• Optimize and maintain compliance in PD laboratory by ensuring 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 and process validations using a qualified scale down model.
• Be responsible for transferring process changes and/or new processes from PD to Manufacturing.
• Act as liaison between PD and Manufacturing for supporting deviations and investigations and for transferring new 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 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 needed.

• Ability to follow cGMPs and procedures with great attention to detail.
• Ability to work in a high-pressure, deadline-driven environment.
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
• Manage time and balance multiple assignments.
• Excellent oral and written communication skills with close attention to detail and accuracy.

• Bachelor’s degree in Science or Engineering required.

• Minimum of five (5) years in a cGMP, pharmaceutical/biological manufacturing environment required.
• Familiarity with aspects of process development.
• Knowledge of FDA cGMP requirements.

• Preferred experience in process validation, scale-down models, and transfer.

• 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).
• Convenient location near Tri-Rail.
• Free shuttle to the Boca Tri-Rail station.

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ADMA Biologics is an Equal Opportunity Employer.