Senior Validation Engineer, Sterility & CQV

Bristol-Myers Squibb Co; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking professionals to lead CQV activities across GMP spaces and analytical systems. You will develop and execute validation strategies, environmental monitoring and sterile process validation, and support investigations and CAPA across development and manufacturing operations.

The role involves hands-on qualification of analytical equipment (HPLC/UPLC, GC, UV-Vis, TOC, particle counters) and collaboration with cross-functional

Qualifications

• Experience with commissioning, qualification and validation activities for GMP spaces.
• Ability to develop and implement CQV strategies for facility, utilities, analytical, laboratory systems.
• Familiarity with environmental monitoring, aseptic processes and cleanroom validation.
• Ability to review data, support investigations and CAPA effectiveness.
• Draft GMP documentation including SOPs, forms, protocols and reports.

Responsibilities

• Support commissioning, qualification and validation activities for GMP and related spaces (office, warehouse, development, QC, sterility/microbiology, GMP production).
• Develop, implement, and maintain CQV strategies for facility, utilities, analytical, and laboratory systems.
• Support environmental monitoring programs, aseptic simulations, cleanroom tests, and VHP/bio-decontamination studies.
• Perform qualification activities for analytical equipment (HPLC/UPLC, GC, UV-Vis, TOC, counters, endotoxin testing, microbiology gear).
• Provide validation support for development, GMP manufacturing, laboratory and operations activities; troubleshoot and review data.
• Expand CQV expertise to process validation, QC assets, cleaning validation, sterility and equipment qualification.
• Own and manage validation areas and project workstreams; support maintained validated state.
• Investigate deviations related to manufacturing, lab, sterility and validation.
• Review data/documentation for investigations, CAPA closure, change control and inspections readiness.
• Draft GMP docs (SOPs, forms, protocols, reports, deviations).

Skills

CQV

Validation

GMP

CAPA

Tools

HPLC/UPLC

Gas Chromatographs

UV-Vis Spectrophotometers

TOC Analyzers

Particle Counters

Endotoxin Testing Instruments

Microbiology Equipment

Job description

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

Job Responsibilities

• Work with the project team, General Contractor, consultants, and cross-functional partners as required to support commissioning, qualification, and validation activities for GMP and supporting spaces, including office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, sterility assurance, and process systems.
• Support environmental monitoring programs, aseptic process simulations/media fills, airflow visualization smoke studies, cleanroom performance qualification, disinfection and sanitization validation, and VHP/bio-decontamination studies.
• Execute qualification activities for laboratory and analytical equipment, including HPLC/UPLC systems, gas chromatographs, UV-visible spectrophotometers, TOC analyzers, particle counters, endotoxin testing instruments, and microbiology laboratory equipment.
• Provide validation support for day-to-day development, GMP manufacturing, laboratory, and operational activities, including troubleshooting, data review, investigation support, and validation impact assessments.
• Expand expertise in additional areas of validation, including process validation, QC assets, cleaning validation, sterility assurance, and analytical equipment qualification.
• Own and manage assigned validation areas or project workstreams while supporting validated state maintenance.
• Apply technical knowledge and abilities to investigate manufacturing, laboratory, sterility assurance, and validation-related deviations.
• Review data and documentation to support investigations, deviation closure, CAPA effectiveness, change control implementation, inspection readiness, and validated state maintenance.
• Draft GMP documentation including but not limited to SOPs, forms, protocols, technical documents, reports, deviations,