Research Engineer

Organization
Discgenics
Job Location
Salt Lake City, UT
Job Description

Seeking a part-time contract/consultant research engineer to support the transition from bench-top manufacturing to large-scale, closed-system production of a cell therapy. A successful candidate has experience with setting up and testing bioreactors and other fluid processing systems. Familiarity with ISO and cGMP standards required, and experience with cell therapy is a plus. The candidate is expected to design, implement and report outcomes from experiments, attend weekly meetings, and contribute to regulatory submissions when needed. 
Responsibilities: 
• Execute laboratory experiments in accurate and timely fashion, including obtaining, setting-up and pilot testing a set of bioreactors, separators and agitators. Test each unit for specific outcomes, and then connect the units to create a single production line. 
• Develop and write study proposals, collect and analyze data, and write detailed study reports to summarize findings. ? 
• Collaborate on laboratory experiments with other R&D personnel. 
• Participate in process development meetings. 
• Participate in design control and quality by design initiatives. 
• Participate in laboratory maintenance activities, such as ordering supplies, calibrating equipment, periodic cleaning, etc. 
• Development of Standard Operating Procedures, Preventive Maintenance Instructions, Change Control Documentation, Requirement Specifications, and Validation activities, where applicable.

Requirements: 

Requirements: 
• Masters degree or PhD preferred in biomedical engineering, chemical engineering, mechanical engineering, biology, molecular biology or related discipline with 2+ years of industry experience. 
• Experience with mammalian cell culture preferred, preferably stem/progenitor cells and chondrocytes. 
• Familiarity with cGMP regulations (21 CFR Part 210/211, 820 and 1271). 
• Knowledge in process and cleaning validations, factory operation, maintenance and system interactions for equipment (product contacted), cleaning and factory utilities is preferred. 
• Must be willing to work with human cells/tissue. 
• Must have strong verbal, written and interpersonal communication skills 

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