Manager Validation Technology US - Equipment / 07-4602

Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind.We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future.Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy.For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City.sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

Responsible for the creation and execution of validation programs, procedures, protocols, and policies. This person is an expert in their area of validation and involves working with customers and quality representatives to develop validation strategies that need to be defended to the FDA and other regulatory body policies. They will present and defend studies and programs to the FDA and other regulatory and quality organizations. Areas of expertise include equipment validation and automated systems. Coordinate/perform test activities necessary to execute validation studiesAssist in the creation of validation programs including the writing of policies and procedures. Also, interpretation and application of regulatory requirements concerning validationPrepare and manage validation project related to their area of expertise including the preparation, review and approval of protocols, reports, plans, and schedulesReview/summarize the results and conclusions of the validation studies.Train and assist with conferring expertise to other validation personnel; maintain knowledge through communication through internal and external sources; and facilitate departmental training and maintain departmental training recordsWe are an equal opportunity employer M/F/D/V

Qualifications:

Bachelor’s degree in science or engineering 6-8 years related experience