Senior Validation & Quality Systems Engineer

Raleigh, NC
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At Fluor, we are proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment that encourages big-picture thinking, brings out the best in our employees, and helps us develop innovative solutions that contribute to building a better world together. If this sounds like a culture you would like to work in, you’re invited to apply for this role.

Job Description:

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

Job ID: 149062BR

City: Raleigh

State: North Carolina

Country: United States

We are an equal opportunity employer. All qualified individuals will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, genetic information, or any other criteria protected by governing law.