CSV Lead

Responsibilities

• Lead end-to-end Computer System Validation (CSV) activities for GxP computerized systems.
• Develop and review Validation Plans, Validation Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
• Execute and oversee IQ, OQ, and PQ activities.
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, and other global regulatory requirements.
• Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
• Perform risk assessments using GAMP 5 methodology.
• Manage deviations, CAPAs, change controls, and periodic reviews.
• Support software implementation, upgrades, migrations, and decommissioning projects.
• Cook up validation activities with IT, Quality Assurance, Engineering, Manufacturing, and Business teams.
• Support internal audits, customer audits, and regulatory inspections.
• Mentor junior CSV engineers and provide technical guidance.

Requirements

• Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
• 8+ years of Computer System Validation experience in the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Strong understanding of GxP regulations and computerized system validation.
• Experience validating enterprise systems such as: LIMS, MES, ERP (SAP), Laboratory Systems, SCADA, PLC/HMI, Manufacturing Execution Systems, Electronic Batch Records (EBR), Quality Management Systems (QMS), Document Management Systems (DMS).