# Engineer II, Process Validation

Hiring organization: [Beckman Coulter](https://career.thegoodapps.co/organizations/beckman-coulter)

Canonical page: https://career.thegoodapps.co/jobs/df81d925-c9d2-4ae1-8fa8-105150a47057

Listed on Beckman Coulter's own careers site. Applications go to them directly.

- Seniority: Mid
- Location: Fargo, ND

## Summary

This role leads process validation projects for pharmaceutical manufacturing at a CDMO, ensuring new therapeutics meet regulatory standards through design, execution, and analysis work. It suits engineers with biologics manufacturing experience who want to apply technical expertise to life-saving medicines in a regulated environment.

_Our summary, not Beckman Coulter's wording._

## Skills named

Design of Experiments (DOE), Risk Assessment, Statistical Analysis, Technical Writing

## Required

- Bachelor's or Master's degree in engineering
- 2+ years of experience
- Experience leading process validation across all three stages in biologics or small/large molecule manufacturing
- Knowledge of global regulatory requirements and cGMP regulations
- Proficiency in technical writing, deviation investigations, root cause analysis, and risk assessments

## Nice to have

- CDMO environment experience
- Sterile fill-finish process and equipment qualifications experience

Apply on Beckman Coulter's site: https://danaher.wd1.myworkdayjobs.com/en-US/DanaherJobs/job/Fargo-North-Dakota-United-States/Engineer-II--Process-Validation_R1314490