Support investigations of aseptic technique deviations, contamination events, and environmental monitoring trends, owning training-related CAPAs; represent the program in regulatory, corporate, and customer audits and maintain alignment with cGMPs, FDA aseptic processing guidance, and EU GMP Annex 1. Objectives/Purpose of Job: To lead the aseptic training and certification team and own the site aseptic qualification program, ensuring personnel are trained, qualified, and maintained in certification for aseptic gowning, aseptic behaviors, contamination control practices, cleanroom operations, and interventions.