Principal Computer System Validation Specialist

Job Summary

Leading the validation strategy for GxP-regulated computerized systems, the full-time Principal Computer System Validation Specialist will develop and execute validation projects, ensure compliance with regulatory requirements, and collaborate with cross-functional teams while working remotely from anywhere in the US.

Key responsibilities

• Lead the planning and execution of validation projects for GxP computerized systems in manufacturing, laboratory, and quality operations
• Author and review CSV deliverables, including Validation Plans, Risk Assessments, and protocols
• Manage audit readiness for validated systems and support internal and external inspections

Required qualifications

• Bachelor's degree in computer science, Engineering, Life Sciences, or a related discipline
• Minimum 5-8 years of experience in computer system validation or IT quality compliance within the pharmaceutical or biotech industry
• Deep understanding of GxP Principles, GAMP 5 lifecycle methodology, and 21 CFR Part 11 / Annex 11 compliance
• Experience leading validation of enterprise and laboratory systems such as LIMS, MES, or ERP
• Strong technical writing and documentation skills