Peter Levy has been involved in process development and process validation for the BioPharmaceutical and related industries for over 30 years. He began providing consulting services to the Pharmaceutical Industry in the areas of Process Development, Manufacturing, Technical Transfer, and Validation in 2007. He received his B.S. degree in Chemistry from Tufts University and M.S. degree in Chemical Engineering from Massachusetts Institute of Technology. Past employers include Biogen, Inc (Director Development Engineering & Validation), Millennium Pharmaceuticals (Director Biologics Process Development), Altus Pharmaceuticals (Director Process Development & Engineering), and Amicon Division of WR Grace & Company (Manager, Process Filtration Applications). His focus has been on downstream processing of recombinant proteins with an emphasis on liquid-solid separations. His experience includes the development of processes and process equipment as well as technical transfer, start-up, and validation of clinical and commercial protein processes. Over the past 25 years, Mr. Levy has been actively involved in Industry Task Forces and in the development of Technical Publications that reflect the consensus views of industry practitioners. He was a member of the PDA Task Force that wrote the original version of Technical Report #15: Industrial Perspective on Validation of Tangential Flow Filtration Validation in Biopharmaceutical Applications , published in 1992 and served as the Chairperson of the Task Force that updated this Technical Report, published in 2009. He was also an active member of the PDA Task Force that wrote Technical Report #42: Process Validation of Protein Manufacturing, published in 2005.