Validation Engineer (Equipment, Facilities, and Utilities)

Validation Engineer – Equipment, Facilities & Utilities (EFU) 

Key Responsibilities

• Execute qualification and requalification activities for GMP equipment, facilities, and utility systems.
• Develop, review, and execute IQ, OQ, and PQ protocols and reports.
• Perform temperature mapping studies for GMP equipment, storage areas, warehouses, cold rooms, incubators, and controlled environments.
• Operate and manage Kaye AVS systems for thermal validation and temperature mapping activities.
• Support equipment and facility revalidation programs in accordance with site validation requirements.
• Analyze validation data and prepare technical reports and summary documentation.
• Support protocol discrepancy management, deviations, CAPAs, and change control activities.
• Ensure vali...