Speaker Biography
Stephen Yu
Stephen K. Yu is currently Principal Process Engineer/Project Manager at BE&K BioPharm. He has successfully conducted risk assessments for several BioPharm clients, and contributed significantly to project ROI. He was previously, Director of Production Engineering at AstraZeneca, and was a member of a global team for the development of a risk-based corporate procedure for the qualification process. For 30 years, Yu has worked on a wide range of pharmaceutical manufacturing operations, including liquid, solid, aseptic, and biotech processes. He is a frequent speaker on the topics of solid dosage, and biotech processing at ISPE and Interphex conferences, and has published on the subject of Biotech Facility Construction. He has in-depth working experience with FDA and EU regulatory compliance requirements. He is the co-leader of the ISPE OSD Baseline Guide Revision Team; and was a member of the ASTM E-2500 Standard Team. He holds a B.S. in Chemical Engineering from New York University.