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Senior Validation Engineer

Katalyst CRO
Salt Lake, UT Contractor
POSTED ON 12/13/2025 CLOSED ON 1/11/2026

What are the responsibilities and job description for the Senior Validation Engineer position at Katalyst CRO?

Roles & 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

Education & Experience :

  • Bachelor's in Engineering
  • 5 years in biopharma validation/process engineering
  • Strong process validation & equipment qualification experience
  • cGMP, FDA/EMA, ICH Q7Q10 knowledge
  • MES, automation, LIMS exposure
  • Cleanroom and hands-on lab skills
  • Strong communication & documentation abilities

Hourly Wage Estimation for Senior Validation Engineer in Salt Lake, UT
$46.00 to $53.00
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