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WAI WONG

Mr. Wong leads the commissioning, qualification and validation practice for Pharmatech’s clients. Mr. Wong brings 20 years of equipment, facility and process validation experience in the pharmaceutical, medical device, and biologic industries. He has earned an international reputation for expertise in validation having demonstrated success in navigating the complex requirements of the FDA, EU and PIC/s compliance. Pharmatech was founded as a qualification and validation firm and Wong shepherds this practice area.

Prior to joining Pharmatech in August 2005, Wai was the West Coast Regional Manager of Validation for Fluor Enterprises, one of the world’s largest, publicly owned engineering, procurement, construction and maintenance services companies. Prior to joining Fluor in 2004, Mr. Wong was a Senior Validation Engineer at Nektar Therapeutics, formerly Inhale Therapeutic Systems, a biopharmaceutical company that develops drugs that are easier to take, safer to use, longer lasting and more effective. Between 1998 and 2001, Mr. Wong was a Project Lead for a Bay Area validation consulting company dedicated to providing expertise to the biopharmaceutical industry. Mr. Wong began his career in the biopharmaceutical industry at Genentech, Inc., considered to be the founder of the biotechnology industry. Genentech uses human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Mr. Wong started at Genentech working as an aseptic filling technician and worked his way up to becoming a shift lead and eventually the role of a process engineer who introduced new equipment and processes into Genentech’s fill-finish operation for both clinical and commercial manufacturing. Mr. Wong has authored multiple articles relating to the biopharmaceutical and medical device industries. He holds a Green Belt in Six Sigma and has been involved in many FMEA exercises at numerous client sites. Mr. Wong earned his B.A. in Molecular and Cell Biology with emphasis on Biochemistry from the University of California at Berkeley. He lives in the San Francisco Bay Area with his wife and children.