CQV & Sterility Validation Engineer II

Bristol-Myers Squibb; Indianapolis (IN); On-site; USD 96,000 - 117,000; Full time

Benefits offered by this job

Health Coverage

Paid Time Off

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking a Validation Engineer II, CQV Sterility Assurance in Indianapolis to support GMP commissioning, qualification, and validation activities for facility and process systems. You will partner with Quality, Manufacturing, Engineering, QC, and Operations to maintain validated state and regulatory alignment.

The role covers aseptic processing, environmental monitoring, analytical equipment qualification, and lifecycle validation.

Qualifications

• BS or MS in scientific related field or equivalent work experience
• 2-5 years of experience in Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical laboratory, quality control, or GMP manufacturing environment
• 2-5 years of validation experience within a GMP environment
• Experience drafting, executing, or reviewing qualification and validation protocols is preferred

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, CAPAs, change controls, test scripts, and summary reports.
• Support Health Authority inspections, internal audits, and department KPI tracking related to validation performance, execution status, and compliance.
• Mentor and cross-train other team members.

Skills

Technical writing

Regulatory knowledge

GMP/CQV principles

Sterility assurance

Environmental monitoring

Documentation practices

Risk management

Team collaboration

Problem solving

Attention to detail

Independent mindset

AI tools usage

Education

BS or MS in scientific field

GMP/validation experience

Tools

HPLC/UPLC

Gas chromatographs

UV-Vis spectrophotometers

TOC analyzers

Microbiology equipment

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking a Validation Engineer II, CQV Sterility Assurance in Indianapolis to support GMP commissioning, qualification, and validation activities for facility and process systems. You will partner with Quality, Manufacturing, Engineering, QC, and Operations to maintain validated state and regulatory alignment.

The role covers aseptic processing, environmental monitoring, analytical equipment qualification, and lifecycle validation.