Equipment Validation Engineer

Equipment Validation Engineer: Design layout of equipment/materials in compliance with ISO, FDA, and GMP standards. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS). Research, study, compile and prepare material on quality control activities, processes and procedures. Prepare and execute Installation, Operational, and Validation document (IQ, OQ and PQ) protocols using centrifuge and incubators. Approve Final Validation Report. Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments

Salary: $87,422/year  

Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)

Requirements: BS or foreign equiv in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 3 months of exp as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, preparing IQ, OQ and PQ protocols, approving final validation report, and using ISO, FDA, and GMP standards