Manager Validation Technology- Cleaning / 06-30482R

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:

As a Manager Validation Technology, individual will provide validation and technical assistance for cleaning validation in support of the manufacture of vaccines at the sanofi pasteur Swiftwater Campus. Responsibilities include writing, executing, reporting, presenting and defending validation studies and programs to regulatory agencies; supporting the creation and execution of validation programs, procedures, protocols, policies, and studies. This individual will accomplish these objectives through close interaction with product development, regulatory, quality assurance, quality control, and other groups within sanofi pasteur.

We are an equal opportunity employer M/F/D/V

Qualifications:

BS in Engineering or scientific field
Minimum 5 yrs experience in a cGMP regulated environment
5-8 yrs of validation experience to include a minimum of 5 yrs cleaning validation
Working knowledge of regulatory (US and Europe) requirements for cleaning validation
Demonstrated experienced in writing/executing cleaning validation protocols and reports
Familiarity with CIP/SIP systems and validation requirements
Excellent interpersonal skills and must be able to work in a cross-functional team-based environment
Excellent oral and written skills