Fred Ohsiek BS

Fred Ohsiek, who earned his BS in Chemistry from the University of South Florida, resides in the NC RDU area. He has 24-plus years of validation experience as an FTE and consultant, with an emphasis on cleaning validation. Before 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, soft gels) in green and brownfield small and large molecule manufacturing projects has provided Fred with a very broad cache of experience. Fred also obtained “cleaning chemistry” experience while working as a senior global Technical Manager at Ecolab (Life Science division).

In his current role as Principal Cleaning Process Consultant, he supports the 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.