The Lead Validation Engineer role is based at the North Carolina manufacturing facility within Kyowa Kirin, a global specialty pharmaceutical company dedicated to developing novel therapies for rare and serious diseases. The position leads daily commissioning, qualification, and computer system validation activities for process equipment, facilities, utilities, and automation systems. Key responsibilities include overseeing the full validation lifecycle from design to operational qualification, ensuring compliance with GAMP 5 and FDA regulations, and supporting process, cleaning, and shipping validation programs. The role appeals to professionals seeking a mission-driven environment where patient needs are central, offering opportunities to lead complex tech transfer projects and drive continuous improvement. This is a fully on-site position with limited travel, fostering a collaborative culture that values inclusive teamwork, resilience, and professional growth.