The Subject Matter Expert for Clean Utilities provides technical expertise and guidance across the life-cycle of clean utility systems within pharmaceutical manufacturing facilities. The SME supports the design, implementation, operation, troubleshooting and continuous improvement of systems that are critical to GMP production environments.
The SME acts as a key technical reference for clean utility systems such as Purified Water (PW), Water for Injection (WFI), Clean Steam, Process Gases and Clean Compressed Air, ensuring systems are designed, operated and maintained in compliance with regulatory requirements and internal quality standards.
Key responsibilities include providing technical oversight for system design reviews, commissioning and qualification activities (FAT, SAT, IQ/OQ/PQ) and ongoing operational support. The SME collaborates closely with engineering, quality, validation, manufacturing and external vendors to ensure systems meet performance, safety and regulatory expectations.
The role also involves supporting root cause investigations, troubleshooting system performance issues and driving continuous improvement initiatives to enhance reliability, efficiency and compliance. The SME may contribute to risk assessments, change controls, deviation investigations and process safety reviews, ensuring that any modifications or upgrades to clean utility systems are properly evaluated and implemented.
Additionally, the SME supports documentation development and review, including system specifications, operating procedures, maintenance strategies and qualification protocols. They may also provide technical mentoring to engineering and operations teams and contribute to long-term site infrastructure planning and capacity strategies related to clean utilities.
Overall, the SME ensures that clean utility systems operate reliably, efficiently and in full compliance with GMP and regulatory expectations, supporting the safe and consistent manufacture of pharmaceutical products.