The Validation Engineer leads, coordinates, and executes validation activities in compliance with current Good Manufacturing Practices (cGMP), corporate quality systems, and applicable regulatory requirements. The role works closely with Quality Assurance, Engineering, Manufacturing, Facilities, and Automation, supporting manufacturing, facilities, utilities, equipment, and computerized systems. It ensures compliance with FDA and global cGMP requirements and data integrity principles (ALCOA+), and owns change controls, protocols, testing execution, reporting, and risk assessments. As a commissioning consultant within the Building Consultancy function, the role assists project teams in delivering building commissioning services. It develops and maintains detailed commissioning schedules and plans, covering pre-commissioning and startup through handover. Responsibilities include overseeing commissioning of building systems, reviewing construction documents and deliverables, writing testing procedures, conducting site observations and testing, and facilitating operations and maintenance staff training. The role is on-site at a client campus three to four days per week; on-site requirements may change based on client needs.
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Job Type
Full-time
Career Level
Mid Level