Senior Validation Engineer, Sterility & CQV

Senior Validation Engineer supporting radiopharmaceutical GMP operations at RayzeBio (Bristol Myers Squibb subsidiary) in Indianapolis. Responsible for developing and maintaining commissioning, qualification, and validation documentation for facility systems, utilities, analytical equipment, and sterility assurance programs in aseptic manufacturing environments.

Responsibilities

• Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, and process systems
• Support environmental monitoring programs, aseptic process simulations, airflow studies, and cleanroom performance qualification
• Execute qualification activities for laboratory and analytical equipment including HPLC, gas chromatographs, and spectrophotometers
• Draft GMP documentation including protocols, SOPs, deviation reports, CAPAs, and validation summary reports
• Investigate manufacturing and laboratory deviations; review data to support investigations and validated state maintenance

Requirements

• BS or MS in scientific field or equivalent work experience
• 4-8 years experience in radiopharmaceutical, injectable, sterile manufacturing, or GMP environment
• 4-8 years validation experience within GMP environment
• Technical writing skills and solid understanding of regulatory validation guidelines
• Working knowledge of GMP requirements, CQV principles, sterility assurance, and contamination control
• Experience drafting, executing, or reviewing qualification and validation protocols preferred
• Strong interpersonal, communication, problem-solving, and data analysis abilities