Manager, Process Monitoring-Swiftwater, PA
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
Sanofi Pasteur's Historic Swiftwater Campus Celebrates 120 Years
HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
Who We Are
The Industrial Operations (IO) site at Swiftwater, Pennsylvania, one of the largest vaccine manufacturing sites in the USA, continues to develop its manufacturing assets for existing and new vaccines and biopharmaceuticals. The Manufacturing Technology group provides a variety of development opportunities to our associates on the job through diverse roles across many functions, and on-site resources for continuous learning.
This position of Manager Process Monitoring, in the Manufacturing Technology (MTech) function of Industrial Operations, performs Continued Process Verification and other statistical analysis to support production and development. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech’s function also provides daily support, for manufacturing and QC, toward industrial performance excellence.
- This individual participates in teams providing guidance for the use of structured methodologies, such as Quality by Design, Design Space, & Process Control Strategies that are to be employed in the course of industrial process design, validation, and control. The individual is technically proficient in the field of process control in applications such as: design space, statistical decision making, control plans, statistical process control, process and product capabilities, and design of experiment. The individual in this position will participate in cross-functional teams from various functions in IO to deliver following:
- Contribute to the definition of critical process attributes for process validation
- Communicate and interpret documented study results within the platform or project
- Provide technical expertise on a given subject matter within area of responsibility
- Implement instruction on new/improved processes to appropriate audience
The Job Responsibilities Include:
- Facilitates the use of statistical thinking promoting the concepts that: all work occurs in a system of interconnected processes, variation exists on all processes, understanding and reducing variation are keys to success
- Drive design space concept through the optimal use of design of experiment and interpretation of data
- Knowledge of Design of Experiment (DOE), Statistical Process Control (SPC), Process Control and Applied Statistics
- Facilitate process control related training for IO personnel
- Promotes application of Process Control for life-cycle design and industrialization of processes, products and associated test methods for Phase 3 and licensed products to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals
- Technical input and/or gap analysis of internal and external Quality/Regulatory guidelines pertaining to process control
Who You Are
Sanofi Pasteur’s IO mission is to improve worldwide human health, as a reliable manufacturer, by delivering high quality, innovative, and affordable products to our customers. You would fit in well with our Sanofi values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).
Education and experience
- PhD or MS in Statistics, Computer Science or other related technical field with 0-1 year relevant industrial experience in a similar role OR
- BS in Statistics, Computer Science or other related technical field with at least 1 year of relevant industrial experience
- Knowledgeable in quality by design, process control, and design of experiments.
- Experience in collaborating with process development, manufacturing, process engineering, quality and regulatory personnel
- Experience in working in teams.
- Meet site IO metrics including HSE, compliance.
- Knowledge of cGMP, Health and Safety, and all other applicable regulations.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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