Qualification: Bachelor’s Degree
- Drive functional excellence initiatives, deliver high quality functional deliverables, and ensure technical excellence for product or technical development
- 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
- Provide significant guidance and approval regarding technical strategies and approaches on product and technology development projects
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures
- Work cross-functionally in identifying and resolving technical issues, take a pro-active role in building bridges across the organization to mitigate issues.
- Drive and evaluate project and department progress, technical development plans, and results.
- Prepare detailed reports based on results of validation and qualification tests or reviews of procedures and protocols
- 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.
- Work with other members to ensure cross-training and provide back-up support.
Bachelor’s degree required in Biomedical engineering, Pharmacists, Chemical engineering or closely related field