Fred Ohsiek

Fred Ohsiek

Principal Cleaning Process Consultant

Validation Resolution

Fred Ohsiek, who earned his BS in Chemistry from University of South Florida, resides in the NC RDU area. He has 24 plus years of validation experience as a FTE and consultant, with emphasis in cleaning validation. Prior to transitioning to pharma his experience includes 7 years in R&D while at the USDA. He has been fortunate to work for 7 major pharmaceuticals (Catalent, AstraZeneca, Boehringer Ingelheim, Teva, Astellas, Bayer, and Novo Nordisk) where he was considered the cleaning validation SME in most of his roles. Working with various routes of administration (OSD, parenteral, softgels) in green and brown field small and large molecule manufacturing projects has provided Fred a very broad cache of experience. Fred also obtained “cleaning chemistry” experience while working as a Sr Global Technical Manager at Ecolab (Life Science division). In his current role as Principal Cleaning Process Consultant, he supports industry by creating tailored justifications, reducing the validation footprint via risk assessments, creating startup CV programs, remediating legacy processes, and increasing manufacturing capability. He was one of the authors of the ISPE Cleaning Validation Lifecycle – Application, Methods, and Controls guidance, and he regularly presents at conferences, nationally and globally.