Senior Quality Engineer
bechtel
Job Description
- Support the Quality Lead in implementing the project Quality Management System with specific focus on CQV readiness during the Engineering and Procurement phases for Lilly Houston Project work executed from the India offices. Facilitate development and execution of the project audit and surveillance program to verify that Engineering and Procurement deliverables support commissioning, qualification, validation, and applicable GMP requirements.
- Review material and service requisitions, quality requirements, supplier data requirements, inspection points, and data & documentation requirements to confirm that GMP-critical systems, Non-Impact systems equipment, utilities, and materials are properly defined for intended use.
- Coordinate with Engineering, Procurement, Supplier Quality, CQV, and project stakeholders to ensure design outputs and procurement packages include requirements for equipment suitability, cleanability, maintainability, calibration, data integrity, traceability, and turnover documentation.
- Support supplier prequalification and quality submittal reviews for GMP-relevant equipment and services, including verification of supplier quality capability, inspection and test requirements, and vendor turnover packages.
- Identify quality conditions, CQV gaps, specification inconsistencies, and potential cGMP compliance risks during Engineering and Procurement reviews; initiate documented actions and follow up through closure using the project Closed Loop Corrective Action process.
- Track nonconformities, audit findings, surveillance observations, and supplier quality issues that may affect CQV readiness, GMP compliance, or project turnover; verify effective closure with responsible Engineering, Procurement, Supplier Quality, and CQV stakeholders.
- Collect, analyze, and report quality metrics for Engineering and Procurement performance, including audit and surveillance completion, action closure, requisition review quality, supplier documentation status, and CQV/GMP readiness indicators.