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

Wellbeing programs

401(k) plan

Paid time off

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Validation Engineer II to support CQV sterility assurance in Indianapolis. You will draft, execute, and maintain qualification and validation documentation for facility, utility, analytical, and laboratory systems.

Collaborate with Quality, Manufacturing, Engineering, and project teams to ensure validated state maintenance and regulatory alignment.

Qualifications

• BS or MS in a scientific field or equivalent experience.
• 2–5 years in radiopharmaceuticals, injectable sterile manufacturing, or GMP environments.
• Experience drafting/ executing qualification and validation protocols preferred.
• Strong technical writing and regulatory understanding required.

Responsibilities

• Support commissioning, qualification, and validation for GMP and related spaces.
• Develop and implement CQV strategies for facility and process systems.
• Support environmental monitoring, aseptic simulations, and cleanroom qualification.
• Execute qualification for analytical equipment (HPLC/UPLC, GC, UV-Vis, TOC).
• Provide validation support for development, GMP manufacturing, and labs.
• Mentor and cross-train team members.

Skills

Technical writing

Regulatory understanding

GMP validation

Analytical problem solving

Team collaboration

Education

BS or MS in a scientific field

Tools

HPLC/UPLC

Gas Chromatographs

UV-Vis spectrophotometers

TOC analyzers

Particle counters

Endotoxin testing equipment

Microbiology lab equipment

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Validation Engineer II to support CQV sterility assurance in Indianapolis. You will draft, execute, and maintain qualification and validation documentation for facility, utility, analytical, and laboratory systems.

Collaborate with Quality, Manufacturing, Engineering, and project teams to ensure validated state maintenance and regulatory alignment.