Senior CQV & Sterility Validation Engineer

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid holidays

160 hours vacation for new hires

Job summary

RayzeBio in Indianapolis is seeking a Senior Validation Engineer, CQV Sterility & CQV, to draft, execute, and maintain qualification and validation documentation for GMP facilities and processes. You will collaborate with Quality, Manufacturing, Engineering, and project teams to ensure systems remain validated and compliant.

The role covers aseptic manufacturing environments, environmental monitoring, analytical equipment qualification, and validation study execution.

Qualifications

• BS or MS in scientific related field (or equivalent work experience).
• 4-8 years of Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical lab, or GMP environment experience.
• Experience drafting, executing, or reviewing qualification and validation protocols is preferred.

Responsibilities

• Support commissioning, qualification, and validation activities for GMP and supporting spaces (office, warehouse, development, QC, sterility/microbiology, GMP production).
• Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, sterility, and process systems.
• Support environmental monitoring programs, aseptic process simulations/media fills, cleanroom qualification, and validation studies.
• Execute qualification activities for laboratory/analytical equipment (HPLC/UPLC, GC, UV-Vis, TOC, particle counters, endotoxin testing, microbiology equipment).
• Provide validation support for development, GMP manufacturing, lab and operations activities including data review and CAPA impact assessments.
• Expand expertise to process validation, QC assets, cleaning validation, sterility assurance, and equipment qualification.
• Own and manage assigned validation areas or project streams while maintaining validated state.
• Investigate manufacturing, lab, and validation deviations and support investigations.
• Draft GMP documents: SOPs, forms, protocols, reports, deviations, CAPAs, change controls, test scripts and summaries.
• Support inspections, audits, and KPI tracking related to validation performance and compliance.
• Mentor and cross-train team members; execute equipment/process validations as needed.

Skills

Technical writing

Regulatory guidelines

GMP

CQV principles

Environmental monitoring

Analytical instrumentation

Risk management

Team collaboration

Problem solving

Education

BS or MS in scientific related field

Tools

HPLC/UPLC

Gas chromatographs

UV-Vis spectrophotometers

TOC analyzers

Particle counters

Endotoxin testing instruments

Microbiology equipment

Job description

RayzeBio in Indianapolis is seeking a Senior Validation Engineer, CQV Sterility & CQV, to draft, execute, and maintain qualification and validation documentation for GMP facilities and processes. You will collaborate with Quality, Manufacturing, Engineering, and project teams to ensure systems remain validated and compliant.

The role covers aseptic manufacturing environments, environmental monitoring, analytical equipment qualification, and validation study execution.