Validation Lead; LIMS​/MES

Validation Lead (LIMS/MES) at Katalyst CRO

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• 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.

Mid-Senior level

Full-time

Quality Assurance

Portland, OR $-$