Systems Validation Specialist (1 Year Contract)

Responsibilities Lead and manage Computerized Systems Validation (CSV) activities for client projects operating within regulated industries, such as validation and compliance activities for automation systems, manufacturing execution systems, industrial control systems, IT infrastructure, building automation systems, and other regulated computerized systems. Participate in Commissioning, Qualification and Validation (CQV) activities and provide compliance guidance throughout project execution. Ensure validation activities are conducted in accordance with GAMP 5, GxP, 21 CFR Part 11, Data Integrity, and other applicable regulatory and industry requirements. Provide subject matter expertise in validation, qualification, and compliance of computerized systems, automation platforms, and business-critical applications. Develop and execute validation strategies to ensure systems remain compliant throughout their lifecycle, from implementation through ongoing operation and maintenance. Prepare, review, and approve validation documentation including User Requirement Specifications (URS), Functional Specifications, Risk Assessments, Validation Plans, Traceability Matrices, IQ/OQ/PQ protocols, validation reports, and related lifecycle documents. Review and approve CSV validation plans, protocols, and final summary reports to ensure they meet regulatory and internal Quality Management System (QMS) standards. Lead investigations into deviations, validation discrepancies, and system-related quality events, including root cause analysis and CAPA implementation. Manage change control activities associated with computerized systems and ensure timely closure of compliance actions. Collaborate with engineering, automation, quality, infrastructure, and project teams to support system implementation, upgrades, migrations, and enhancement projects. Support audit readiness initiatives and participate in internal audits, client audits, and regulatory inspections where required. Provide…