Computer System Validation (CSV) Lead - Pharma Industry

Key Responsibilities:

• Lead and manage end-to-end CSV and C&Q lifecycle activities, including:
  URS → Risk Assessment → IQ / OQ / PQ → UAT → System Release → Retirement
• Define CSV strategies, validation plans, and execution models aligned with GAMP 5 and GxP regulations.
• Ensure adoption of risk-based validation approaches across automation and GxP systems.

• Lead validation for automation and control systems, including:
  • DeltaV DCS / Batch systems
  • PLC & SCADA systems
  • BAS / BMS / EMS / HMI systems
• Support validation of large GxP IT and digital manufacturing systems in pharma environments.
• Review and approve key validation deliverables such as URS, FRS, RTM, test protocols, deviations, and summary reports.

• Ensure compliance with FDA, EMA, and global regulatory requirements, including data integrity and ALCOA+ principles.
• Act as the ...