Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s sterility assurance programs and contamination control strategies, providing technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The position offers technical leadership for the parenteral process team and mentorship within the TSMS team, engaging in both site-specific and external activities to establish robust contamination control strategies. The role involves oversight of sterility assurance programs at the manufacturing floor level, authoring and executing performance qualifications, analyzing microbial and manufacturing data, supporting root cause investigations, and participating in audits. The Sterility Assurance Scientist will work cross-functionally to implement objectives and deliver on business and quality goals. Flexibility is required to support production schedules, including occasional extended hours, off-hour work, and travel for training and implementation. The position may require repetitive motion, standing or walking for long periods, and working in cleanroom environments with appropriate PPE.