IT CSV Engineer

Location: Hybrid (US site or remote with periodic travel) Engagement: 6–12-month contract (extendable) Start: Within 2–4 weeks Hours: Full-time Rate: Competitive (W2/C2C + approved expenses) Position Overview Our client, a global biopharmaceutical manufacturer, is seeking an IT CSV Lead to drive Computer System Validation (CSV/CSA) strategy and execution across a portfolio of GxP systems (MES, LIMS, QMS, Data Historian, and ERP). This individual will act as the validation workstream lead, partnering with IT, QA, and Manufacturing to ensure all systems meet GAMP 5, 21 CFR Part 11, Annex 11, and data integrity requirements. The ideal candidate brings deep knowledge of risk-based validation (CSA) and hands-on experience leading validation efforts from project initiation through inspection readiness for global pharma environments. Key Responsibilities • Own and lead all CSV/CSA activities across assigned IT systems, ensuring alignment with global validation strategy and site quality requirements. • Develop and maintain Validation Plans, Risk Assessments, Traceability Matrices, and Test Protocols (IQ/OQ/PQ). • Provide strategic direction on validation approach for both legacy and new systems, leveraging risk-based and CSA principles. • Lead cross-functional reviews with QA, IT, and business process owners to ensure deliverable consistency and compliance. • Direct and mentor validation engineers and documentation specialists, ensuring high-quality execution and audit-ready documentation. • Oversee vendor assessments, supplier qualification, and validation of GxP cloud/SaaS solutions (AWS/Azure-hosted). • Interface with auditors and regulators, presenting validation strategy, documentation, and supporting evidence. • Drive continuous improvement initiatives for validation templates, SOPs, and processes across the organization. • Support change control, deviation management, CAPA, and periodic review cycles for validated systems. Required Experience • 10+ years Computer System Validation experience in pharma/biotech, including leadership of validation workstreams. • Proven delivery of CSV/CSA for GxP-regulated systems: MES (Syncade, PAS-X), LIMS (LabVantage, LabWare), QMS (Veeva, TrackWise), ERP (SAP S/4), and Data Historian (OSI PI). • Expert understanding of GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, and data integrity principles. • Track record leading validation strategy for multi-site or global rollouts. • Familiar with Agile/DevOps validation and digital transformation projects (cloud migration, SaaS qualification). • Strong authoring and reviewing skills for validation lifecycle documentation. • Excellent stakeholder management and communication across IT, QA, and Manufacturing.