Validation Engineers in Manufacturing

Key Responsibilities

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