Fred Ohsiek earned his BS in Chemistry from the University of South Florida and currently resides in the Research Triangle (RDU) area of North Carolina. He has over 27 years of validation experience as both a full-time employee and a consultant, specializing in cleaning validation across all phases, from development to routine monitoring.
Throughout his career, Fred has worked for seven major pharmaceutical companies—Catalent, AstraZeneca, Boehringer Ingelheim, Teva, Astellas, Bayer, and Novo Nordisk—as a full-time employee, serving as the Cleaning Validation Subject Matter Expert (SME) in most of his roles. His experience spans various routes of administration and dosage forms, including oral solid dosage (OSD), parenteral, topical, softgel, and combination products. His involvement in both greenfield and brownfield projects across small- and large-molecule manufacturing facilities has provided him with a broad range of industry expertise.
Fred also gained extensive experience in cleaning chemistry while serving as Senior Global Technical Manager in Ecolab’s Life Sciences division.
As Associate Director of Cleaning Validation at Eliquent Life Sciences, Fred and his team support the pharmaceutical industry by developing tailored scientific justifications, reducing the validation footprint through risk assessments, establishing cleaning validation programs for new facilities, remediating legacy processes, and enhancing manufacturing capabilities.
Fred was also a contributing author of the ISPE Cleaning Validation Lifecycle – Application, Methods, and Controls guidance document and regularly presents at national and international industry conferences.
