Lead Validation Engineer

Role: Lead Validation Engineer supporting GMP radiopharmaceutical manufacturing at RayzeBio's Indianapolis facility. Primary objectives include leading validation activities for facility, utilities, equipment, analytical, and computerized systems, ensuring compliance from construction through clinical development and commercialization. Responsibilities encompass developing validation strategies, managing validation programs, reviewing documentation, leading deviation investigations, and supporting regulatory inspections. The position also involves process improvements, technology onboarding, and team mentorship. Qualifications: BS/MS in a scientific or engineering discipline, 5+ years in GMP radiopharmaceutical or injectable manufacturing, with extensive validation experience. Skills include technical writing, regulatory knowledge, leadership, decision-making, and cross-functional collaboration. High-value specifics include radiopharmaceutical modality, GMP environment, validation program leadership, and experience supporting regulatory audits. The role reports to leadership, involves collaboration across quality, engineering, operations, and project teams, and requires working in a GMP cleanroom environment with some physical demands. Location: Indianapolis, hybrid setup, with potential for travel.