Requires a Masters degree in Chemical Engineering, Pharmaceutical Engineering, or a related field plus two years or Bachelors degree plus five progressive years of validation engineering experience. Must have at least two years of experience in each of the following 1. Utilizing and applying chemical engineeringpharmaceutical engineering principles in validating Supervisory Control and Data Acquisition SCADA, and Human Machine Interface HMIs for pharmaceutical manufacturing processes; 2. Ensuring manufacturing compliance with FDA regulations, including 21 CFR Parts 11, and 21 CFR Part 210211; 3. Developing and reviewing Process Flow Diagrams, PIDs, system manuals, equipment specifications, and technical reports; 4. Writing and executing validationqualification protocols and analyze critical process parameters and critical quality attributes for Fluid Bed Dryer, Tablet Compression Machines, and Tablet Hardness testers; 5. Generating and executing computer systems validation protocols for production equipment in an FDA regulated environment; 6. Participating in the commissioning, qualification, and validation of Total Organic Content Analyzers, HVAC and Building Automation System, Packaging Lines, Controls and Automation, and Process Equipment; and 7. Being responsible for ensuring data integrity of the laboratory systems including High Pressure Liquid Chromatography, Ultra Performance Liquid Chromatography, UVVis, Particle Size Analyzer, Refractometer, Polarimeter, and Fourier Transformed Infrared Spectroscopy. Will accept any suitable combination of education, training, or experience.
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