What the work is
Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
On a typical day
- 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 production of pharmaceuticals, electronics, or other products.
- 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.