Manager, Sterility Assurance Aseptic Processing / 08-4907

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:

•Provide Sterility Assurance assistance, technical advice and training to site to promote and achieve compliance with site procedures, GQDs, and to ensure inspection readiness•Create, review, approve procedures relating to Sterility Assurance•Observes media simulations for compliance to established procedures, prepares/reviews data packs, writes and issues summary reports•Participate in aseptic training of operations staff, observe aseptic operations for adherence to proper aseptic practices•Perform GQD gap assessments and prepare remediation plans•Develop and manage projects to address business and Sterility Assurance needs of site, including capital and resources required •Upon remediation of gaps, ensure procedures are updated and systems are in place and maintained to ensure continued compliance•Performs Sterility Assurance review and approves change controls, validation protocols, reports, assists in deviation writing/review•Interfaces with domestic and foreign regulatory inspectors on Sterility Assurance related issues•Perform other duties as assigned by SupervisorWe are an equal opportunity employer M/F/D/V

Qualifications:

•BS Microbiology, biotechnology or related discipline•Preferably at least one year experience directly supporting an aseptic manufacturing operation in a quality, manufacturing or validation related function •Working knowledge of media fills, aseptic gowning, aseptic practices, microbiology, disinfection•Demonstrated ability to support and work within a highly energized team-based organization•Demonstrated ability to plan and execute multiple projects concurrently•Must be able to work weekends and off shift as required •Strong analytical and critical thinking skills•Strong verbal and written communication skills