Employer will accept a Masters degree in Mechanical Engineering, Biotechnology, or a related field.br br The position also requires completion of a universitylevel course, research project, internship, or thesis, or 6 months of experience, in each of the followingbr br 1. Validation plan and protocol developmentexecution. Prospective, Concurrent, Retrospective, and Revalidation for Electromechanical and Software systems. Periodic review of Legacy Equipments;br 2. Validation lifecycle methods, Risk Assessments, User Requirement Specifications URS, FactorySite Acceptance Test FATSAT, Installation Qualification IQ, Operational Qualification OQ, and Performance Qualification PQ;br 3. Quality Management System tools, continuous improvement methodologies; and products and processes;br 4. Plastics materials, properties, manufacturing processes, and product assembly; andbr 5. Minitab or similar statistical software, data recordinganalysis.

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