Designs or plans protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
This career is part of the Science, Technology, Engineering and Mathematics cluster Engineering and Technology pathway.
A person in this career:
- Analyzes validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Prepares validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.
- Coordinates the implementation or scheduling of validation testing with affected departments and personnel.
- Studies product characteristics or customer requirements and confers with management to determine validation objectives and standards.
- Creates, populates, or maintains databases for tracking validation activities, test results, or validated systems.
- Prepares, maintains, or reviews validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Resolves testing problems by modifying testing methods or revising test objectives and standards.
- Prepares detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
- Identifies deviations from established product or process standards and provides recommendations for resolving deviations.
- Directs validation activities, such as protocol creation or testing.