# Senior Engineer, Process Validation

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

Canonical page: https://career.thegoodapps.co/jobs/0bd5a8a5-ed0f-40dc-935b-f06ec9c6a47b

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

- Employment type: full time
- Seniority: Senior
- Salary: 100000 – 130000 USD per year

## Summary

This role leads validation projects for pharmaceutical and biotechnology manufacturing, designing and executing strategies to ensure new medicines meet regulatory standards before commercialization. It suits experienced engineers who want to combine technical expertise with mentorship in a mission-driven environment focused on life-saving therapies.

_Our summary, not Beckman Coulter's wording._

## Skills named

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

## Required

- Bachelor's or Master's degree in engineering
- 5+ years of experience in process validation
- Experience leading process development and validation across all three stages in biologics or small/large molecule manufacturing
- Knowledge of global regulatory requirements and cGMP regulations
- Proficiency in technical writing including deviation investigations, root cause analysis, and risk assessments
- 15% travel to sites for validation projects, inspections, audits, and client visits

## Nice to have

- Experience with packaging and shipping validation of final product container closure configurations
- Prior experience in a CDMO environment or client-facing roles

Apply on Beckman Coulter's site: https://danaher.wd1.myworkdayjobs.com/en-US/DanaherJobs/job/USA---Remote/Senior-Engineer--Process-Validation_R1314479