Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076) 3 Key ConsultingEngineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)Thousand Oaks, CaliforniaRemoteOur ideal candidate will have 3+ years of experience in tech transfer of Biologics Drug Substance upstream and/or downstream required (Cell Culture, Harvest, Chromatography, filtration, UFDF unit ops), Knowledge of upstream and downstream processes/equipment; scale-up factors, process deviations, quality attributes. Biologics process knowledge: Knowledge of processes (cell culture, harvest, chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill) and equipment; scale-up factors, process deviations, quality attributes.
Senior Human Factors Engineer, Instructions For Use/Medical Device – Remote (JP13164) 3 Key ConsultingSenior Human Factors Engineer, Instructions For Use/Medical Device – Remote (JP13164)Thousand Oaks, CaliforniaRemoteSupports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/drug delivery devices. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans.