Commissioning And Qualification Lead Consultant - 2454352

🔍Title: Senior Computer System Validation Specialist

📍Location: East Puerto Rico | Work Setting: Onsite | Availability: Immediate

Position Overview

Our client is seeking a Senior Computer System Validation (CSV) Specialist with strong C&Q, CQV, Engineering, Validation, and compliance SME expertise to support Drug Product operations in a regulated manufacturing environment.

Key Responsibilities

• Lead CSV, C&Q, CQV, qualification, and validation activities throughout the project lifecycle.
• Provide SME support across design, engineering, commissioning, qualification, and validation activities.
• Develop, review, and execute validation plans, protocols, reports, URS, risk assessments, and qualification documentation.
• Support validation of computerized systems, equipment, facilities, utilities, HVAC, and environmental systems.
• Review and support FAT/SAT, commissioning packages, and qualification deliverables.
• Apply cGMP, data integrity, and validation compliance requirements.
• Manage validation-related deviations, CAPA, troubleshooting, root cause analysis, and issue resolution.
• Coordinate execution with Engineering, Quality, Manufacturing, vendors, and contractors.
• Support audits, inspections, regulatory submissions, and validation program readiness.

Key Skills & Proficiencies

• CSV / C&Q / CQV / Validation Lifecycle
• Commissioning & Qualification / FAT / SAT / IQ / OQ
• Risk-Based Validation / Risk Assessments / Root Cause Analysis / CAPA
• cGMP / Data Integrity / Compliance
• Engineering & Validation Documentation
• Technical Writing / Document Management / KPI Tracking
• SME Support / Cross-Functional Coordination / Project Execution
• CDOCS / Kneat / Maximo