Bioprocess Engineer II

COMPANY:

Discovery Solutions seeks applicants for a permanent position with one of our clients, a biotechnology company developing cell and immunotherapy products designed to strengthen each patient’s immune system and potentially outsmart disease and eliminate cancerous or infected cells.

LOCATION:

El Segundo, CA. 

ESSENTIAL FUNCTIONS:

• Support troubleshooting and mitigation efforts for the resolution of deviations investigations, and process issues. Perform root cause analysis and recommend corrective and preventive actions.
• Execute experiments to support process development and optimization efforts.
• Provide technical support during tech transfer and scale-up to the cGMP suite.
• Train manufacturing personnel in equipment and process operations.
• Manage, analyze, and identify trends in data. Aid in organization of data for statistical process control.
• Draft documents including batch documentation, qualification protocols, evaluation protocols/reports, investigation reports, and standard operating procedures (SOPs).
• Provide equipment engineering support for process with a focus on single-use technologies.
• Support FAT/SAT (if needed), commissioning, and validation from a process perspective, draft SOPs for equipment and define user specifications.
• Perform other duties as required and assigned.

EDUCATION & EXPERIENCE:

• BS or MS in Chemical Engineering/bioengineering or related fields with experience in cell culture.
• 3 - 5 years of industrial/cGMP experience in process bioengineering.
• Six-sigma training and/or experience with SPC is preferred.
• Design of experiment training or experience is preferred.
• Strong understanding of compliance and cGMP considerations.

KNOWLEDGE, SKILLS, & ABILITIES

• Strong experience in mammalian cell-culture and related equipment such as Cell-stacks, Wave Bioreactors and Xcellerex bioreactors.
• Experience with cell banking operations.
• Experience with cell separation operation equipment like K-Sep.
• Experience with X-ray irradiators and control-rate freezers is preferred.
• Has good aseptic technique.
• Knowledge of basic statistics.