Clean Utilities CQV Lead

The Clean Utilities CQV Lead oversees commissioning, qualification, and validation of critical clean utility systems such as WFI, purified water, clean steam, compressed air, and gases supporting production activities.

Key Responsibilities:

• Lead CQV for clean utilities (Purified Water, WFI, Clean Steam, Pharmaceuticals Gases, etc.)
• Develop and implement qualification protocols and management plans for all utility systems.
• Coordinate system start-up, testing, and troubleshooting with engineering and vendors.
• Review and approve URS, design documentation, and commissioning records.
• Ensure compliance with GMP and regulatory requirements for clean utilities.
• Manage the resolution of deviations and documentation of change controls.
• Support utility mapping and validation sampling plans.
• Liaise with stakeholders to ensure clean utility readiness for manufacturing.

Requirements:

• Engineering degree or scientific discipline.
• Minimum 7 years' CQV experience, specializing in clean utility systems in pharma environments.
• In-depth knowledge of regulations, guidelines, and best practices for clean utilities.
• Strong leadership, technical, and report-writing skills.