# Lead Validation Engineer

Hiring organization: [Bristol Myers Squibb](https://career.thegoodapps.co/organizations/bristol-myers-squibb)

Canonical page: https://career.thegoodapps.co/jobs/56886431-5dde-4417-a885-2cbcb1dccb53

Listed on Bristol Myers Squibb's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Location: Indianapolis, IN
- Salary: 124449 – 150803 USD per year

## Summary

This role leads validation and commissioning activities for a radiopharmaceutical manufacturing facility, ensuring GMP compliance as the operation transitions from construction to clinical and commercial production. It suits someone with deep manufacturing validation expertise who can independently manage complex programs while guiding a technical team through regulatory requirements and process improvements.

_Our summary, not Bristol Myers Squibb's wording._

## Skills named

Good Manufacturing Practice (GMP), Process Validation, Risk Assessment, Root Cause Analysis, Technical Writing

## Required

- BS or MS in scientific or engineering discipline or equivalent work experience
- 5+ years in radiopharmaceutical, injectable, or regulated GMP manufacturing
- 5+ years of validation experience in GMP-regulated environment
- Led complex validation programs and cross-functional initiatives
- Strong technical writing and document review skills
- Deep understanding of regulatory validation and lifecycle management expectations
- Leadership and problem-solving ability
- Work independently while influencing cross-functional teams

## Nice to have

- Prior experience mentoring engineers or leading project workstreams
- Experience with process validation, cleaning validation, computer system validation, equipment qualification, and QC assets
- Applies AI to improve team execution and decision-making

Apply on Bristol Myers Squibb's site: https://bristolmyerssquibb.wd5.myworkdayjobs.com/en-US/BMS/job/Indianapolis---RayzeBio---IN/Lead-Validation-Engineer_R1604504