Sterility Assurance EM Manager / 08-4983

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:

This candidate will support and supervise a team of analysts compiling, reviewing batch related environmental monitoring data. Data is evaluated against the EM program requirements, summarized and presented in batch records to support release of MRs, NTs, FBs, FCs and Product Development Investigational batches. Data includes results from tests including viable air, non-viable air, surface, personnel monitoring and room parameters. This position is responsible for: • Act as a liasson between SA EM Data Review Group and MFFP, Planning, QA Batch Release, Quality Assurance and Quality Control to complete advanced planning and frequent coordination. • Identifying, Initiating and Completing Incident Investigations, by performing root cause analysis and setting attainable resolutions, • Assigning work and training employees in basic job duties and on the more difficult aspects of the same or related work,• Resolving problems and monitoring work to ensure completion, • Performs routine and annual performance appraisals, • Work consists primarily of widely diverse duties and responsibilities requiring analytical, constructive and/or innovative thinking to develop solutions."We are an equalopportunity employer M/F/D/V"

Qualifications:

Education/Qualifications:• Bachelor of Science in Life Science required, Microbiology preferred. • 5-10 years or experience needed with directly supporting an aseptic manufacturing operation in a quality, manufacturing or compliance or validation related function • In depth knowledge of cGMPs, BPRs and SOPs, Vaccine Manufacturing and/or Filling.• Excellent communication & writing skills are required• Must have knowledge and experience in environmental monitoring, contamination control and aseptic practices. • Must be able to work nights and weekends and a flexible schedule as required.• Demonstrated ability to support and work within a highly energized team-based organization• Demonstrated ability to plan and execute multiple projects concurrently• Strong analytical and critical thinking skills• Previous supervisory experience preferred