Equipment Validation Engineer
· Author and revised system life cycle deliverables, including Impact Assessment, Data Integrity Assessment, User Requirement Specification, Validation Plan, Commissioning Plan, Installation/Operational/Performance Qualification Protocols, Trace Matrix, and Validation Summary Report, following client procedures and Good Automated Manufacturing Practices.
· Conduct validation testing of new or existing equipment, in accordance with company protocols and external regulatory standards.
· Perform Installation qualification on the assets by verifying engineering drawings, schematics, system build, and ensuring minimum requirements are met.
· Conduct risk assessments and accordingly developed validation strategies for new, proposed, or modified systems.
· Assess client systems and identified any potential Part 11 gaps to ensure data integrity best practices are enforced.
· Work closely with Engineering / Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.
· Prepare, maintained, or reviewed validation and compliance documentation, such as engineering change controls, schematics, and protocols.
· Ensure completeness of testing via the development of traceability matrices that mapped requirements to testing.
· Evaluate equipment related deviations, discrepancies, non-conformances, and change control for completeness and impact on process/product.
This position requires a minimum of a Bachelor’s degree in mechanical engineering or a closely related field.