Process Development Engineer - Boca Raton, United States - Brightpath Associates LLC
Description
The Senior Process Engineer, Process Development 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.
Qualifications
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.
Education Requirements:
Bachelor's degree in Science, Engineering, or a related field is required.
Experience Requirements:
A minimum of ten (10) years of experience in a cGMP, Pharmaceutical/Biological manufacturing environment is required. Familiarity with many aspects of process development is required. Knowledge of FDA cGMP requirements is required.
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