Validation Lead(LIMS/MES)

2 weeks ago


Beaverton, OR, United States Katalyst Healthcares and Life Sciences Full time

Roles & Responsibilities:

  • Lead and manage validation activities for LIMS and MES implementations, upgrades, and integrations.
  • Develop and review Validation Master Plans (VMPs), Validation Protocols (IQ, OQ, PQ), and Test Scripts in compliance with GAMP 5 and company policies.
  • Oversee validation deliverables across the System Development Life Cycle (SDLC) including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Traceability Matrices.
  • Perform and document risk assessments, impact assessments, and change control validations for LIMS/MES systems.
  • Ensure compliance with 21 CFR Part 11, EU Annex 11, GxP, and Data Integrity requirements.
  • Collaborate with business users and technical teams to validate system configurations, interfaces, and data migration activities.
  • Conduct periodic reviews, requalification, and system audit readiness for validated systems.
  • Train and mentor validation engineers and coordinate validation activities with cross-functional project teams.
  • Support regulatory and internal audits by providing validation documentation and responses.


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