Pharmaceutical Ops & Technology
Description
Provides process-engineering support for design, construction, start-up & commissioning and validation, of a GMP manufacturing facility. Initially, will entail some travel to Project Engineering Firms offices in England, and an operating facility in RTP. Will be an integral part of a team providing technical engineering and construction support for clean utilities, CIP/SIP, cell culture and purification unit operations and associated equipment. Develops and leads execution of commissioning protocols, 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. Aids in the development of junior process engineers.
Qualifications
BS or MS degree in an engineering field with eight years of related industry experience. Process Engineering/Construction experience in Biotech industry supporting Clean Utilities, CIP/SIP, Cell Culture, Centrifugation, Chromatography, and Ultra filtration unit operations. Familiar construction sequencing, planning/scheduling system start-up and commissioning activities including operating and troubleshooting of DCS automation. Experience with documentation requirements for GMP manufacturing facilities including: Change Control and validation systems.
Education
Bachelors or Masters degree in chemical, mechanical, biochemical or related engineering field.