Role V&V Engineer
Work location Glasgow, DE (Onsite)
3 Positions • Prepare validation and performance qualification protocols for new and/or modified processes, systems or equipment.
• Ensure system compliance with Good Manufacturing Practice, Current Good Laboratory Practice, Current Good Documentation Practices, and FDA regulations such as 21 CFR Part 11 and Part 820 • Work with users and project engineers to define system needs and represent user needs, translating user requirements to logic diagrams and program statements for the purposes of test and validation.
• Develop OQ test cases and provide input towards IQ, PQ protocols
• Execute IQ and OQ protocols
• Perform Test Method Validation to finalize the testing methods.