CQV Validation Engineer - Sterility & GMP

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

Benefits offered by this job

Health coverage

401(k) plan

Paid time off

Job summary

RayzeBio in Indianapolis seeks a Validation Engineer II to lead CQV sterility and validation activities across facility and analytical systems. You will collaborate with QA, Manufacturing, Engineering, and QC to ensure validated state maintenance and regulatory compliance.

Responsibilities include drafting and executing qualification protocols, supporting environmental monitoring, cleaning validation, and process validation, plus mentoring team members in a GMP environment.

Qualifications

• BS or MS in a scientific field or equivalent
• 2–5 years in Radiopharmaceutical/sterile manufacturing or GMP environment
• 2–5 years of validation experience in GMP environment
• Experience drafting/ executing qualification and validation protocols

Responsibilities

• Support commissioning, qualification, and validation activities for GMP spaces and production areas
• Develop CQV strategies for facility, analytical, and process systems
• Provide validation support for day-to-day GMP manufacturing and laboratory activities
• Draft GMP documentation and support inspections and audits

Skills

Technical writing

GMP knowledge

CQV principles

Environment monitoring

Education

BS or MS in scientific field

Tools

HPLC/UPLC

Gas chromatographs

UV-Vis spectrophotometers

TOC analysers

Particle counters

Endotoxin testing instruments

Microbiology lab equipment

Job description

RayzeBio in Indianapolis seeks a Validation Engineer II to lead CQV sterility and validation activities across facility and analytical systems. You will collaborate with QA, Manufacturing, Engineering, and QC to ensure validated state maintenance and regulatory compliance.

Responsibilities include drafting and executing qualification protocols, supporting environmental monitoring, cleaning validation, and process validation, plus mentoring team members in a GMP environment.