Careers

·       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.

Qualification:

This position requires a minimum of a Bachelor’s degree in mechanical engineering or a closely related field.