Utility Validation Engineer

Position: Utility Validation EngineerLocation: IllinoisDuration: Long TermJob OverviewWe are seeking a Utility Validation Engineer to support utility system validation and qualification activities in a GMP manufacturing environment. The role involves leading qualification activities, preparing validation documentation, supporting commissioning, and collaborating with Engineering, Quality, Manufacturing, and other cross-functional teams to ensure compliance with cGMP and FDA requirements.Key ResponsibilitiesAuthor specifications and supporting documentation, including URS, RA, and FS.Lead commissioning testing for GMP utility systems.Develop and execute IQ/OQ/PQ qualification protocols.Support qualification of WFI and Purified Water systems.Lead qualification of clean steam, compressed air, and process gas systems.Perform temperature mapping and airflow/smoke studies for HVAC and cleanroom qualification.Use Kaye Validators and temperature/humidity data loggers for qualification activities.Manage multiple qualification activities, schedules, and deliverables.Lead cross-functional meetings and document meeting notes and action items.Support project forecasting and planning for upcoming qualification activities.Collaborate with Engineering, Process, and Production teams to resolve technical issues.Provide technical expertise and recommend process improvements.Maintain compliance with cGMP, FDA requirements, company policies, and safety procedures.Required QualificationsBachelor s degree in Engineering, Science, or a related field.2 5 years of experience in GMP utility validation or qualification.Experience with WFI, Purified Water, clean steam, compressed air, and HVAC systems.Experience with Kaye Validators and temperature/humidity data loggers.Experience working in a GMP manufacturing environment.Experience preparing SOPs, validation protocols, and technical reports.Knowledge of FDA regulatory requirements and cGMP standards.Strong critical-thinking and technical-writing skills.Strong communication, organizational, and cross-functional collaboration skills.