Senior CQV & Sterility Validation Engineer

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

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