Michelle M. Gonzalez, was formerly Senior Principal Corporate Engineer - Director (now retired), with Amgen Inc. in Thousand Oaks, California. Ms. Gonzalez has had an extensive career in industry leadership activities dealing with facilities engineering, process systems design, and management of construction projects with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, and Amgen; she is now involved with her own research projects and biopharmaceutical industry technical consulting. Ms. Gonzalez holds an MS in Architecture from the Pontificia Universidad Javeriana in Bogotá, Colombia. She is a member of AIChE, and ASME’s Bioprocessing Equipment (BPE) Standard, where she has served as Chair of the Surface Finish Subcommittee, and voting member of the BPE Main Committee and Certification Subcommittee. For the past five years she has also been a member of the Advisory Board for INTERPHEX, the leading annual biopharmaceutical trade show. As an active member of The International Society for Pharmaceutical Engineering (ISPE), she does presently serve as a member of the Membership Development Committee; Pharmaceutical Engineering Committee and Reviewers; Annual Meeting Planning Event Committee; and the Steering Committee of the Critical Utilities Community of Practice. Ms. Gonzalez has also been a participating member in the preparation of ISPE’s “Biopharmaceutical Manufacturing and Process Development Baseline® Guide” (2004); “Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water and Steam Systems” (2007); Second Edition of the “Water & Steam Baseline® Guide” (2011); “Good Practice Guide for Process Gases” (2011); “Good Practice Guide for Ozone Sanitization of Pharmaceutical Water Systems” (2012); and "Good Practice Guide for Quality Laboratory Facilities (2012). She has also been a regular technical speaker and contributing writer to ISPE’s Pharmaceutical Engineering and other technical journals, President of the ISPE’s Greater Los Angeles Chapter (2007-2008), and the author and editor of ISPE's Glossary of Applied Terminology for the Pharmaceutical Industry.