Jenn Walsh is an Associate Director within the Manufacturing Science and Technology group at Bristol-Myers Squibb. Her expertise is in Validation and Technology Transfer of drug product processes (non-sterile/bio-sterile), cleaning cycle development/validation and sterile systems performance qualification. Jenn is a trained Kaizen leader and Six Sigma black belt and leads the BMS Product Robustness program for US/PR sites, seeking to ensure reliable process performance and on-time product delivery. Previous experiences include Validation roles within both Merck & Schering Plough. Jenn is currently co-chair of the ISPE Lifecycle Approach to PV Implementation team which endeavors to provide practical examples and tools for application of the lifecycle approach. She was also a co-author for the ISPE Stage 3 Continued Process Verification (2012) and Evaluation of Impact of Statistical Tools on Process Performance Qualification Outcomes (2013) Discussion Papers. Jenn holds an engineering degree from Drexel University.