Occupation: Validation Engineers
Validation Engineers
Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Reported Job Titles (8)
- Corporate Quality Engineer
- Product Quality Engineer
- Quality Assurance Engineer
- Quality Engineer
- Quality Management Systems Engineer
- Reliability Engineer
- Supplier Quality Engineer
- Validation Specialist
Core Tasks (20)
- Study product characteristics or customer requirements to determine validation objectives and standards.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
- Maintain validation test equipment.
- Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Communicate with regulatory agencies regarding compliance documentation or validation results.
- Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Recommend resolution of identified deviations from established product or process standards.
- Design validation study features, such as sampling, testing, or analytical methodologies.
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
- Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
- Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
- Draw samples of raw materials, intermediate products, or finished products for validation testing.
- Direct validation activities, such as protocol creation or testing.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
- Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
- Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
Supplemental Tasks (1)
- Devise automated lab validation test stations or other test fixtures or equipment.