Validation Engineers

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.

Resolve testing problems by modifying testing methods or revising test objectives and standards.

Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.

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.

Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.

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.

Devise automated lab validation test stations or other test fixtures or equipment.