Job: Principal Engineer

Jobing Description

Serve as process engineering technical lead and subject matter expert to support cell culture and harvest processes for the commercial manufacture of biopharmaceuticals, including process performance monitoring and troubleshooting and the development and implementation of process improvement strategies. Lead process technology transfers and scale-up to commercial scale, including development of process models. Evaluate and develop new technologies and incorporate operational excellence into the design of processes, equipment, and operations. Develop and execute engineering test plans and experiments and apply statistical analysis and sound judgment for interpretation of data. Provide strong leadership of cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives. Manage and supervise a team of process engineers, set appropriate objectives and priorities, overcome obstacles; and deliver results within project timelines. Review and improve manufacturing and operating procedures, provide technical support for investigations and for corrective and preventive actions, and identify and address process and raw material risks. Build and maintain effective collaborations with Manufacturing, Facilities & Engineering, EH&S, Quality Assurance, Regulatory Affairs, and Validation. Infrequent travel to domestic and
international sites may be required. Basic Qualifications Doctorate degree and 2 years of directly related experience

OR

Master s degree and 6 years of directly related experience

OR

Bachelor s degree and 8 years of directly related experience

OR

Associate s degree and 10 years of directly related experience

OR

High school diploma / GED and 12 years of directly related experience
Preferred Qualifications Advanced degree in Biochemical or Chemical Engineering

Fundamental expertise and experience in the design, control, and operation of large-scale cell culture processes and equipment (e.g., bioreactor, centrifugation harvest)

Knowledge and understanding of cell biology, protein expression, cell culture, media development, and protein structure and function

Experience in providing process technical support of commercial manufacturing operations

Knowledge and understanding of statistical methods, first-principles modeling, and software tools for modeling fluid flow, mixing, mass and energy balance, and facility utilization

Experience in technology transfer and scale-up for cell culture and harvest processes

Demonstrated skills in building high-performing teams and cross-functional partnerships and in leading cross-functional teams to advance complex projects to completion

Knowledge and understanding of regulatory and cGMP requirements, including successful preparation and defense of CMC regulatory submissions and support of regulatory inspections

Strong communication and technical writing skills