Emergent BioSolutions
Director, Global Validation
Stephanie began working at Emergent BioSolutions in 2022 as the Director of Global Validation. She has spear-headed many initiatives including standardizing the global validation processes, implementing digital validation, worked to create an engineering library for the standardization of Engineering Specifications, advancing Manufactuing towards the implementation of an MES system, and advocates for the professional development of the engineering and validation staff through joining professional organization and getting them access to a variety of industry journals and guidance documents. She joined Amgen in the engineering department in 2019. Prior to joining Amgen, she worked for Takeda as Associate Director of Commissioning and Qualification in the global validation group supporting plasma operations throughout the US, EU, and Asia. She is also a subject matter expert for commissioning and qualification of facilities, utilities, equipment and automation. Before working for Takeda, Stephanie worked for Baxter as the computer validation manager for a manufacturing facility in Los Angeles which won the ISPE FOYA award in 2018. In her early career, she joined Wyeth, now Pfizer, working as the Quality Validation Lead for automation systems at the facility in North Carolina.
Stephanie holds a Master’s degree in engineering management from the University of Wisconsin, at Madison, Master’s degree in Quality Systems from San Diego State University, and a Bachelor of Science in Electrical Engineering from North Carolina State University. She is a member of the ISPE Commissioning and Qualification COP Steering Committee.
