Principal Computer System Validation Specialist
VirtualVocations
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
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$62 - $72 per hour
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