Validation Engineer, Sterility & CQV

Role: Validation Engineer II, CQV Sterility Assurance supporting GMP radiopharmaceutical manufacturing in Indianapolis. Responsibilities: develop and execute qualification and validation strategies for facility, utilities, analytical and laboratory systems, including environmental monitoring, aseptic process simulations, cleanroom qualification, and analytical equipment validation. Collaborate across Quality, Manufacturing, Engineering, QC, and Operations teams; support validation lifecycle activities, deviations, investigations, and GMP documentation. Requirements: BS/MS in a scientific field; 2-5 years' validation experience in sterile, radiopharmaceutical, or GMP environments; proficiency in validation protocols, GMP regulations, and sterile processing. Preferred: experience with analytical instrumentation, contamination control, and environmental monitoring. HighValue: aseptic manufacturing, radiopharmaceuticals, validation lifecycle, GMP, environmental monitoring, analytical lab systems, regulatory compliance. WorkSetup: on-site in Indianapolis; includes handling radioactive materials and working in GMP cleanroom settings.