Pharmaceutical Ops & Technology
Description
Provides process-engineering support for a GMP manufacturing facility. Provides engineering technical support and troubleshooting for cell culture and purification unit operations and associated equipment. Develops technical specifications for validation protocols, reviews validation testing and provides technical resolution for protocol deviations. Leads the design, implementation, commissioning and validation for new processing equipment and modifications to existing equipment within their responsible area. Participates in cross-functional teams to implement change and improve on existing processes.
Qualifications
Bachelor’s degree with four years of related industry experience. ing experience in Biotech industry supporting Cell Culture, Micro filtration, Centrifugation, Chromatography, and Ultra filtration unit operations. Familiar with operation and troubleshooting of DCS automation. Experience with documentation requirements for GMP manufacturing facilities including: Change Control and validation systems.
Education
Bachelor’s degree in chemical, mechanical, biochemical or related engineering field.