Engineer Process I

Role Summary

The Process Engineer I provides process development and transfer support for IgG immunotherapy production. He/she provides updates to Process Development Management to ensure compliance issues are being met. He/she maintains compliance in the PD laboratory and executes process development/evaluation studies as well as process validations using a scale-down model. As a key member of the PD group, he/she provides support for 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 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 cGMP production environment as necessary.

Qualifications

• Required: At least three (3) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment, familiarity with many aspects of process development is expected.
• Required: Knowledge of FDA cGMP requirements.

Education

• Bachelor’s degree in Science or Engineering.

Skills

• Ability to follow the cGMP’s and procedures with great attention to detail.
• Able to work in high-pressure, deadline-driven environment.
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
• Possess time management skills and be able to balance multiple job assignments at once.
• Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendations.