Validation Engineer
Indianapolis
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 5-8 yearsEducation: bachelorsSkills: ["Judgment","Organizational skills","Communication","Risk assessment","Problem-solving"]Lead and coordinate commissioning and validation activities in compliance with cGMP, corporate quality systems, and FDA/global regulatory requirements. Partner closely with Quality Assurance, Engineering, Manufacturing, Facilities, and Automation to develop commissioning schedules, execute testing, and manage change controls. Oversee building systems commissioning (HVAC, plumbing, electrical, controls, BMS, low voltage), review design documents, and produce validation/reporting deliverables while ensuring ALCOA+ data integrity.
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