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MES Validation Lead - CSV, GMP & FDA​/EMA Expert

Job in Hillsboro, Washington County, Oregon, 97104, USA
Listing for: SupportFinity™
Full Time position
Listed on 2026-07-10
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 90000 - 120000 USD Yearly USD 90000.00 120000.00 YEAR
Job Description & How to Apply Below

Katalyst CRO seeks a seasoned Validation Professional to oversee computerized validation programs in a GMP-regulated setting. You will develop and execute validation protocols, ensure compliance with FDA/EMA/GxP requirements, and manage test plans across ERP, LIMS, Val Genesis, and SCADA systems.

Ideal candidates bring 5+ years of CSV experience and hands-on Factory Talk Pharma Suite proficiency, driving quality and regulatory readiness in a fast-paced CRO environment.

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