Speaker Biography
Michelle Gonzalez
Michelle M. Gonzalez, was formerly Senior Principal Corporate Engineer - Director (now retired), with Amgen Inc. in Thousand Oaks, California. She has extensive experience spanning a range of leadership activities in facility design, engineering and management of projects. Since relocating to the United States, she has held technical and managerial positions of increasing responsibility in mechanical engineering with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Flour Daniel and Amgen. For the last 23 years she has focused her professional expertise on the biopharmaceutical industry. González holds an MS in architecture from the Pontificia Universidad Javeriana in Bogota, Columbia. She has been a regular lecturer at the Stanford School of Engineering and holds professional memberships in the American Institute of Chemical Engineers (AIChE) and the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) Standards, where she serves as chair of the BPE's subcommittee on surface finishes, voting member of the executive and main committees as well as the certification, and dimensions and tolerances subcommittees. For the past 19 years, Gonzalez has been an active Member of ISPE where she has been a regular speaker, member of the Membership Committee (MSC), North American Educational Committee (NAEC) and Body of Knowledge Committee (BOKC); President of the Greater Los Angeles Chapter (2007-2008), and a participating member on the preparation of the ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems, the Biopharmaceutical Manufacturing Facilities Baseline® Guide, Packaging, Labeling, and Warehousing Operations Baseline® Guide, and Quality Laboratory Facilities Baseline® Guide,. She is the author and editor of ISPE’s Glossary of Applied Terminology for the Pharmaceutical Industry. Gonzalez has authored various technical papers dealing with materials of construction for the biopharmaceutical industry including "single use" products technology, facilities programming, pilot plants and biotechnology process systems.