Senior Validation & Quality Systems Engineer
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.
Basic Job Requirements
• Accredited four (4) year degree or global equivalent in applicable field of study and fourteen (14) years of work-related experience is required.
• The ability to communicate effectively with audiences that include management, coworkers, clients, vendors, contractors, and other stakeholders.
• Demonstrate an elevated level of technical knowledge in one or more of the manufacturing sectors served by ATLS.
• Analytical approach to problem solving and identifying potential solutions.
• Technical and business writing skills.
• Basic understanding of design, engineering, procurement, and engineering design change control procedures.
• Ability to resolve problems and to be comfortable in complex projects or business environments.
• Ability to travel periodically to other Fluor offices or client locations in support of projects or routine business needs.
Other Job Requirements
• The ability to communicate effectively with audiences that include management, coworkers, clients, vendors, contractors, and other stakeholders.
• Demonstrate an elevated level of technical knowledge in one or more of the manufacturing sectors served by ATLS.
• Analytical approach to problem solving and identifying potential solutions.
• Technical and business writing skills.
• Basic understanding of design, engineering, procurement, and engineering design change control procedures.
• Ability to resolve problems and to be comfortable in complex projects or business environments.
• Ability to travel periodically to other Fluor offices or client locations in support of projects or routine business needs.
Preferred Qualifications
• 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.
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.
Benefits Statement: Fluor is proud to offer a comprehensive benefits package designed to promote employee health, wellness, and financial security. Our offerings include medical, dental and vision plans, EAP, disability coverage, life insurance, AD&D, voluntary benefit plans, 401(k) with a company match, paid time off (personal, bereavement, sick, holidays) for salaried employees, paid sick leave per state requirement for craft employees, parental leave, and training and development courses.
Market Rate Statement: The market rate for the role is typically at the mid-point of the salary range; however, variations in final salary are determined by additional factors such as the candidate’s qualifications, relevant years of experience, geographic location, internal pay equity, and prevailing market conditions for the specific role.
Notice to Candidates: Background checks are carried out as part of any conditional offer made, including (but not limited to & role dependent) education, professional registration, employment, references, passport verifications and Global Watchlist screening.
To be Considered Candidates: Must be authorized to work in the country where the position is located.
Salary Range: $160,000.00 - $302,000.00