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. As a key member of the PD group provide support for Manufacturing, Quality Control/Quality Assurance, and Regulatory departments.

The Process Engineer I will:

• 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

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.

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 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)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station