Principle Consultant
CurrentChemical Engineer with experience in biopharmaceutical process and project engineering, and commissioning and qualification. Wide range of experience in lab, pilot, and large scale environments. Large capital project involvement, process development, plant operation, and manufacturing support.Experience with upstream and downstream biotechnology process equipment including bioreactors, media/buffer prep, CIP/SIP, centrifuge, filtration.Experience with critical and non-critical utilities including purified water, WFI, clean steam and gases.Experience with aseptic processing including parts washers, autoclaves, aseptic filling lines.Experience with equipment procurement, user requirements definition, design review/design qualification, system risk assessment, C&Q planing, execution and reporting.Experience with quality management systems including change controls, deviation/CAPA, training, etc.