What does a Validation Engineer do?
Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
- Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Design validation study features, such as sampling, testing, or analytical methodologies.
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
- Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
- Direct validation activities, such as protocol creation or testing.
- Draw samples of raw materials, or intermediate and finished products for validation testing.
- Identify deviations from established product or process standards and provide recommendations for resolving deviations.
- Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
- Procure or devise automated lab validation test stations or other test fixtures and equipment.
- Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
- Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
- Communicate with regulatory agencies regarding compliance documentation or validation results.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Maintain validation test equipment.
- Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
- Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.
- Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.