California Licensed LIMS Validation Specialist

Job Summary

To support validation activities in a regulated pharmaceutical environment, the hybrid Lab Ware LIMS Validation Specialist will execute validation tasks, author and review documentation, and collaborate with cross-functional teams over a 12+ month contract.

Key Responsibilities

• Execute validation activities for Lab Ware LIMS in compliance with GxP, FDA, and industry regulations
• Author, review, and execute validation documents including URS, Risk Assessments, IQ, OQ, PQ, and Validation Summary Reports
• Collaborate with business, quality, and IT teams to gather and document system requirements

Required Qualifications

• 5+ years of Computer System Validation experience in pharmaceutical or biotechnology environments
• Hands-on experience validating Lab Ware LIMS applications
• Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11, and GAMP 5
• Experience preparing and executing validation documentation such as URS, IQ, OQ, PQ, and Risk Assessments
• Strong understanding of change controls, deviations, CAPAs, and periodic review processes