Doug Harbrecht is a Microbiologist with over 30 years of experience in the medical device and biopharmaceutical industries. He has been an independent consultant since 2012. Prior to that he worked for 20 years at Boston Scientific as manager of microbiology, sterilization and biocompatibility, and later as a Fellow in the corporate sterilization group. He has extensive experience in ethylene oxide, radiation (gamma and e-beam), and liquid chemical sterilization validation, reprocessing of devices, microbiology laboratory testing and management, controlled environment monitoring, biocompatibility, audit of contract laboratories and sterilization facilities, and support of regulatory submissions. He is also an active member on several AAMI sterilization standards committees.