Senior Validation Engineer
Katalyst CRO
Salt Lake City, Japan Full Time Engineering Jobs Japan
Job Description
Senior Validation Engineer
Location: North Salt Lake, UT | Salary: $64,000.00 – $83,000.00 (3 days ago)
Responsibilities
- Develop and execute validation strategies
- Lead Process Validation & PPQ activities
- Perform C&Q for equipment, utilities, and facility systems
- Run risk and gap assessments
- Maintain equipment master data and support change controls
- Execute floor-level validation in GMP cleanrooms
- Coordinate sampling and data collection
- Support recipe authoring, data trending, and automation needs
- Train and guide cross‑functional teams
Qualifications
- Bachelor's in Engineering
- 5+ years in biopharma validation/process engineering
- Strong process validation & equipment qualification experience
- cGMP, FDA/EMA, ICH Q7/Q10 knowledge
- MES, automation, LIMS exposure
- Cleanroom and hands‑on lab skills
- Strong communication & documentation abilities
Seniority level
Associate
Employment type
Contract
Job function
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Posted April 20, 2026