Michael Birochak

Principal Engineer / Senior Gxp Auditor at The FDA Group, LLC

Michael Birochak is an experienced technical leader and engineer with a strong focus on automation and system validation in the pharmaceutical and biotechnology sectors. Currently serving as the Technical Leader for CAR T Implementation at Celgene, Michael is responsible for managing shop floor equipment data extraction into an OSI PI database. Additional roles include Principal Engineer and Senior GxP Auditor at The FDA Group, and Senior MES Consultant at The Quantic Group, where responsibilities involve ensuring MES validation documentation meets regulatory standards. Michael has extensive experience as a Sr. Automation Engineer at Global Automation Partners and has led various projects for major companies including Genentech, Lilly, Merck, and Pfizer. Michael holds a Bachelor's degree in Electronic Engineering from the University of Hartford.

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