Job Summary
Bechtel is seeking a Senior Quality Engineer for the Manufacturing and Technology team, based in Gurugram, to support the Pharmaceutical Project in Houston. The Senior Quality Engineer will monitor and verify project quality activities to ensure compliance with approved standards, specifications, project procedures, GMP expectations, and schedule requirements through audits, surveillances, and quality reviews. The role includes supporting GMP- and CQV-related verification of engineering and procurement deliverables, including quality requirements, supplier documentation, inspection and test requirements, traceability, data integrity, turnover records, and readiness for commissioning, qualification, and validation. The Senior Quality Engineer will identify quality conditions, CQV gaps, and opportunities for improvement within the Project scope of work, and will support the Quality Lead in implementing the Project Quality Plan, audit plan, supplier quality program, Closed Loop Corrective Action process, quality metrics, and lessons learned program.
Major Responsibilities
Support the Quality Lead in implementing the project Quality Management System with specific focus on CQV readiness during the Engineering and Procurement phases of 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.
Education and Experience Requirements
Bachelor's degree in an engineering, science, or technical discipline from an accredited college or university and a minimum of 11 years relevant industry experience including 7 plus years of GMP / Pharmaceuticals experience.
Required Knowledge and Skills
Quality Management System knowledge, skills, and experience within regulated GMP environments within Pharma, Biotech, or Medical Devices supporting site startups, major expansions, or large capital projects with responsibility for QMS requirements.
An understanding of aseptic manufacturing, utilities, equipment qualification, and data integrity principles (preferred 4 parenteral facilities). Working knowledge of GMP regulations, inspection readiness, validation, and quality systems.
Extensive knowledge of Quality Assurance Requirements, and their application to construction, engineering, acquisition services, supplier quality, materials management, and regulatory requirements.
Knowledge of advanced techniques for assessment, event investigation, cause analysis, human performance, and corrective action
Demonstrated knowledge of design, procurement, construction, start-up, commissioning, and operation. Demonstrated knowledge of current construction industry trends, innovations, and regulatory construct, for industry.
Auditor professional certification from an accredited certification body. Previous experience in development and maintenance of quality assurance programs related to the construction of Pharmaceutical / Life Science facilities.
Flexibility to respond to urgent project requests and/or changing priorities. Ability to work under pressure and with minimal supervision. Demonstrated ability to work with people of varied backgrounds and objectives.
Total Rewards/Benefits
For decades, Bechtel has worked to inspire the next generation of employees and beyond! Because our teams face some of the world's toughest challenges, we offer robust benefits to ensure our people thrive. Whether it is advancing careers, delivering programs to enhance our culture, or providing time to recharge, Bechtel has the benefits to build a legacy of sustainable growth. Learn more at Bechtel Total Rewards
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As a global company, Bechtel has long been home to a vibrant multitude of nationalities, cultures, ethnicities, and life experiences. This diversity has made us a more trusted partner, more effective problem solvers and innovators, and a more attractive destination for leading talent.
We are committed to being a company where every colleague feels that they belong-where colleagues feel part of "One Team," respected and rewarded for what they bring, supported in pursuing their goals, invested in our values and purpose, and treated equitably. Click here to learn more about the people who power our legacy.
Bechtel is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, disability, citizenship status (except as authorized by law), protected veteran status, genetic information, and any other characteristic protected by federal, state or local law. Applicants with a disability, who require a reasonable accommodation for any part of the application or hiring process, may e-mail their request to acesstmt@bechtel.com
