Senior Validation Engineer, GMP Radiopharma CQV Leader

Bristol-Myers Squibb; Indianapolis (IN); On-site; USD 107,904 - 130,754; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

Stock opportunities

Job summary

RayzeBio in Indianapolis is seeking a Senior Validation Engineer to draft and execute CQV documents for a GMP radiopharmaceutical facility. You will develop strategies for CQV across offices, warehouses, QC, and production areas while supporting commissioning and validation activities.

The role requires 4–8 years in Radiopharmaceutical or injectable GMP manufacturing and validation, with strong technical writing and regulatory knowledge and an independent, collaborative mindset.

Qualifications

• BS or MS in a scientific field or equivalent work experience.
• 4-8 years of Radiopharmaceutical or injectable GMP manufacturing experience.
• 4-8 years of validation experience within a GMP environment.

Responsibilities

• Draft and execute CQV documents and protocols for a GMP radiopharma facility.
• Develop CQV strategies for GMP spaces including office, warehouse, development, QC, sterility and GMP production.
• Support commissioning, validation, deviation investigations, CAPAs, and change controls.
• Mentor and cross-train team members and support Health Authority inspections.

Skills

Technical writing

Regulatory guidelines

GMP experience

Team collaboration

Independent mindset

Interpersonal skills

AI tools usage

Education

BS or MS in scientific field

Job description

RayzeBio in Indianapolis is seeking a Senior Validation Engineer to draft and execute CQV documents for a GMP radiopharmaceutical facility. You will develop strategies for CQV across offices, warehouses, QC, and production areas while supporting commissioning and validation activities.

The role requires 4–8 years in Radiopharmaceutical or injectable GMP manufacturing and validation, with strong technical writing and regulatory knowledge and an independent, collaborative mindset.