What are the responsibilities and job description for the Validation Lead(LIMS/MES) position at Katalyst CRO?
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.
