Validation Engineer

Job TitleJob Description What You'll DoConfigures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the fieldDrafts and implements validation protocolsExecutes validation activities (e.g., equipment set up, material readiness, and work orders)Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)Executes and manages validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trendsIdentifies and assesses risks and escalates to senior engineers or management to develop and implement mitigation strategiesDevelops, implements, and maintains equipment and system qualifications and validation protocolsPrepares and presents report packages for implementation into standard operating procedures (SOPs)Prepares validation master plans for facilities, equipment, and systemsProvides guidance to junior engineers for drafting and implementing validation studiesCollaborates cross-functionally to ensure successful integration of CQV activities into projectsOther duties, as assignedMinimum RequirementsBachelor's degree in Engineering with 5 years of experience in validation activities in facilities, commissioning, and systems qualificationPrior experience leading teams or projectsTemperature mapping, Thermal Data Loggers, and pre- and post-calibration procedure experience