Validation Engineer, Sterility & CQV

Role: Validation Engineer II supporting GMP sterile manufacturing and facility validation activities at RayzeBio's Indianapolis site, a Bristol Myers Squibb subsidiary in oncology radiopharmaceuticals. Responsibilities: develop, implement, and execute commissioning, qualification, and validation strategies for facility, utility, analytical, and process systems; support environmental monitoring, sterilization, and laboratory equipment qualification; troubleshoot validation issues, review data, and draft GMP documentation; assist with inspections and audits; mentor team members. Requirements: BS/MS in a scientific field; 2-5 years' validation experience in radiopharmaceutical, sterile, or GMP manufacturing environments; familiarity with qualification protocols, GMP regulatory guidelines, contamination control, and analytical instrumentation; strong technical writing, organizational, and communication skills. Preferred: experience with microbiology, environmental monitoring, and aseptic processing validation. High-Value: focus on sterile, aseptic environment validation, environmental monitoring, sterilization validation, and GMP compliance; supporting radiopharmaceutical manufacturing. Work setup: Indianapolis-based role with GMP cleanroom environment; physical demands include handling radioactive materials; no specific travel requirements stated.