Beth Kroeger STERIS Corporation

Beth Kroeger is a Technical Services Senior Manager for the Life Sciences Division of STERIS Corporation.  She currently provides global technical support related to process research cleaners, cleaning validation, and critical environments. Additionally, Beth frequently speaks on these topics for the Institute of Validation Technology (IVT), United States Pharmacopeia (USP), International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and the National Institute for Bioprocessing Research and Training.

Beth has over 25 year’s industry experience in R&D involving infectious diseases and Biopharmaceutical and Oral Solid Dose manufacturing operations. Prior to her current position, Beth was employed by Janssen Biologics and Biotest Pharmaceuticals, where her areas of expertise included large scale fermentation systems, both continuous perfusion, and fed-batch, and downstream operations including large scale purification processing, viral removal, UF, and final fill. Beth has held positions in Operations, Cleaning Validation, Compliance, and as the manufacturing lead on a cross-functional team responsible for the scale-up and technical transfer of 4 biopharmaceuticals.  In her role in manufacturing and compliance, she conducted hundreds of investigations relating to excursions, malfunctions, failures, and errors. Beth earned a B.S. in Biochemistry from the University of Missouri, St. Louis and is an Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program for the Spring semester 2020. She is currently on the ISPE task force to draft Cleaning Validation Guidelines for Biopharmaceutical Operations and recently completed a Fermentation Technology course at MIT, July 2017.