Masters Degree in Industrial or Manufacturing Engineering. Must have 2 years of experience in maintenance and validation engineering in an FDAregulated pharma industry. Must have experience in planning, executing, and installing Roller Compactor, Tablet Coating machines and examining HVAC system design in compliance with FDA 21 CFR Part 11; CAPA development in TrackWise; calculating MKT; and executing IQQQPQ in equipment validation. Must have strong understanding of cGMP production environment, manufacturing and cleaning processes Must be proficient with AutoCad, Minitab, SAP and MS Office suite and analytical thinking and problem solving. Ability to execute validations per Standard Operatingbr Procedures and regulatory guidelines required.
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