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:
- Studies product characteristics or customer requirements to determine validation objectives and standards.
- Analyzes validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Develops validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Prepares detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.
- Maintains validation test equipment.
- Conducts validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Communicates with regulatory agencies regarding compliance documentation or validation results.
- Prepares, maintains, or reviews validation and compliance documentation, such as engineering change notices, schematics, or protocols.
- Recommends resolution of identified deviations from established product or process standards.
- Designs validation study features, such as sampling, testing, or analytical methodologies.