Validation Engineer (Equipment, Facilities, and Utilities)

Validation Engineer – Equipment, Facilities & Utilities (EFU) 

Location: Singapore, Tuas.
Industry: Pharmaceutical Manufacturing | Life Sciences

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 validation activities are executed in compliance with approved procedures and GMP requirements.
• Coordinate qualification activities with Engineering, Operations, QA, QC, Facilities, and Validation teams.
• Review calibration status and ensure readiness of validation instruments and data loggers.
• Maintain accurate validation documentation and support inspection readiness activities.
• Participate in continuous improvement initiatives related to validation and qualification programs.

Requirements

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• Experience supporting Equipment, Facilities, and Utilities Qualification within pharmaceutical, biotechnology, or GMP-regulated manufacturing environments.
• Hands-on experience using Kaye AVS systems for thermal validation activities.
• Strong experience performing temperature mapping studies and thermal validation.
• Familiarity with GMP equipment qualification and facility revalidation programs.
• Experience preparing and executing IQ, OQ, and PQ protocols and reports.
• Knowledge of GMP regulations, Data Integrity requirements, and validation lifecycle practices.
• Experience supporting deviation investigations, CAPA implementation, and change control processes.
• Strong technical documentation and report writing skills.