CQV Sterility Validation Engineer II

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

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Validation Engineer II, CQV Sterility & CQV in Indianapolis to draft, execute, and maintain qualification documentation for GMP facilities and sterile processes.

You will partner with Quality, Manufacturing, Engineering, and QA teams to ensure systems stay validated and compliant, support environmental monitoring, and contribute to commissioning and performance qualification in a fast-paced radiopharmaceutical setting.

Qualifications

• BS or MS in scientific related field or equivalent work experience.
• 2-5 years of Radiopharmaceutical/sterile GMP experience.
• 2-5 years of validation experience in GMP environments.

Responsibilities

• Draft, execute, and maintain qualification/validation documents for GMP facilities and sterile processes.
• Develop and implement CQV strategies for facility, utilities, analytical, lab, and process systems.
• Support environmental monitoring, aseptic process simulations, and cleanroom qualification.

Skills

Technical writing

Regulatory understanding

GMP knowledge

Independent mindset

Motivation & organization

Team experience GMP

Multidisciplinary GMP

Ethics & confidentiality

AI tools

Education

BS or MS in scientific field

Tools

HPLC/UPLC systems

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, seeks a Validation Engineer II, CQV Sterility & CQV in Indianapolis to draft, execute, and maintain qualification documentation for GMP facilities and sterile processes.

You will partner with Quality, Manufacturing, Engineering, and QA teams to ensure systems stay validated and compliant, support environmental monitoring, and contribute to commissioning and performance qualification in a fast-paced radiopharmaceutical setting.