Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
<ul><li>Study product characteristics or customer requirements to determine validation objectives and standards.</li><li>Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.</li><li>Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.</li><li>Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.</li><li>Maintain validation test equipment.</li><li>Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.</li><li>Communicate with regulatory agencies regarding compliance documentation or validation results.</li><li>Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.</li><li>Recommend resolution of identified deviations from established product or process standards.</li><li>Design validation study features, such as sampling, testing, or analytical methodologies.</li><li>Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.</li><li>Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.</li><li>Resolve testing problems by modifying testing methods or revising test objectives and standards.</li><li>Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.</li><li>Draw samples of raw materials, intermediate products, or finished products for validation testing.</li><li>Direct validation activities, such as protocol creation or testing.</li><li>Coordinate the implementation or scheduling of validation testing with affected departments and personnel.</li><li>Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.</li><li>Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.</li><li>Assist in training equipment operators or other staff on validation protocols and standard operating procedures.</li></ul>