Kathleen (Kate) Waters is a Senior Principal Engineer at Genentech responsible for ensuring that engineering capital projects are compliant with business processes and quality requirements, and is also championing the development of QRM and QbD for facilities and equipment. She been involved in manufacturing IT, PLM for the process industries, batch control systems, validation, and regulated industry compliance for the past 15 years. Waters is a member of International Society of Automation (ISA), International Society of Pharmaceutical Engineering (ISPE) and PAR (Process Automation Roundtable). She holds a Bachelor’s Degree in chemistry and math, and a Master’s Degree in analytical chemistry from Western Michigan University.