Job Description

The Process Engineer I will provide process development and Transfer support for IgG Immunotherapy Production. Provide updates to Process Development (PD) Management team on a regular basis to ensure compliance issues are being met. Responsible for maintaining compliance in PD laboratory and executing 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 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.
• 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.

Education Requirements:

• Bachelor’s degree in Science or Engineering

Experience Requirements:

• At least three (3) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment, familiarity with many aspects of process development is expected.
• Knowledge of FDA cGMP requirements is an essential pre-requisite for this position.