Senior Validation & Quality Systems Engineer

This position provides consulting services to clients, reviews designs prepared by the Project Development Studio and acts as a resource within the ATLS Division of Fluor to audit projects and advise clients regarding compliance and CQV strategy. This is a client-facing technical role and reports to the head of the Project Development Studio in Greenville South Carolina. The PDS is a global team of subject matter experts, process architects, process, and equipment engineers within the ATLS Division of Fluor. Our team serves the life sciences, advanced manufacturing, semiconductor, data center and battery manufacturing industries. It delivers as many as fifty projects per year. The essential job duties for this position are as follows: • Stay abreast of developments in the FDA regulations and ISPE guidance that influence Life Science facility design. • Evaluate conceptual facility designs for Life Science clients and develop summary level assessments describing how the proposed facility configuration complies with current or evolving regulations. • Consult with clients and Fluor design teams as projects progress through basic and design to ensure that they are robust from a regulatory compliance perspective. • Provide clients with technical and regulatory advice. Build client relationships through credibility. Become their trusted partner. • Lead the development of validation master plan development projects. • Leverage existing client relationships to sell your services and the services of the PDS team. • Communicate effectively at all levels order to maintain liaison with individuals and units within or outside the department or project structures • Employ decision-making authority and recommendations that have a significant impact on regional or business line Quality policies and programs • Serve as the project Quality Representative on medium to large projects, if necessary • Prepare project audit schedules, discipline activity plans for the quality function, and audit reports (internal and external), noting non-conformances and verifying effective corrective action • Assist in developing an orientation program to ensure that the project teams are familiar with the requirements of the Project Quality Plan; including other Quality matters, if required • Act as lead Quality auditor and follow up on audit findings and corrective actions • Other duties as assigned• Accredited four (4) year degree or global equivalent in engineering field of study and fourteen (14) years of work-related experience; a recognized professional certification or registration in the applicable field, if required; some locations may have additional or different qualifications in order to comply with local requirements • Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and visitors • Job related technical knowledge necessary to complete the job • Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines • Ability to attend to detail and work in a time-conscious and time-effective manner• Experience working with manufacturing, research and development, clinical laboratories or other FDA-regulated operations within the Life Sciences Industry. • Expert understanding of FDA regulations. • Ability to conduct FDA compliance audits. • Experienced with the preparation of validation master plans for new facilities. • Familiar with the preparation and submission of NDA, ANDA and 510 (k) documentation. • Expert knowledge of change control practices, deviation handling and documentation. • Experience collaborating with regulatory authorities.• Participate in Fluor University courses for continued learning experiences. • Utilize the Fluor Knowledge Management processes to capture, support and leverage relevant knowledge to enhance project execution, if appropriate. • Actively participate and represent Fluor at industry trade shows, annual meetings, or other professional gatherings for the industries we serve. • Leverage established relationships with equipment suppliers as a result of delivery past projects.