Veeva LIMS SME Consultant

About the role

Seeking a Veeva LIMS Subject Matter Expert / Lead Information Systems Engineer with 5+ years of CSV/validation experience in a GxP-regulated environment to support Veeva LIMS implementation, validation, testing, and lifecycle management.

Responsibilities

• Lead/support Veeva LIMS implementation and validation from requirements through deployment and closeout.
• Develop/review URS, risk assessments, validation plans, test scripts, traceability matrices, validation reports, and SOPs.
• Support configuration, functional/integration testing, UAT, defect resolution, data migration, and interfaces.
• Apply CSV/CSA, GxP, and risk-based validation principles.
• Support change controls, deviations, CAPAs, periodic reviews, and audit/inspection readiness.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Collaborate with Quality, IT, Laboratory, and business stakeholders.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years of CSV/validation experience in Pharma, Biotech, or GxP environments.
• Hands-on Veeva LIMS implementation/validation/lifecycle experience.
• Strong knowledge of CSV/CSA, GxP, risk-based validation, and data integrity.
• Experience with validation documentation, testing, traceability, and regulatory compliance.
• Strong communication, organization, project management, and problem-solving skills.