Process Validation Engineer, Swiftwater, PA

Job description

Who We Are

Industrial Operations (IO) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi Pasteur provides associates in IO a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education.

The Position

This position of Industrial Operations Associate Process Validation Engineer, within the Manufacturing Technology (MTech) function of Industrial Operations, performs activities supporting the development and validation of industrial downstream processes including Formulation, Filling, Lyophilization and Inspection. The mission of the MTech function is to deliver robust and efficient processes & testing with associated knowledge to transfer to Manufacturing & QC. The Mtech function also provides daily support to manufacturing and QC toward industrial performance excellence. The individual in this position will:

·  Plan and execute process development and process validation studies supporting product transfers and new product introductions. Assure adherence to internal procedures / quality guidelines and external regulatory requirements from development through licensure. The individual in this position will contribute to cross-functional teams from various functions in Vaccine Industrial Affairs (VIA) to deliver the following:

Accountabilities:

·  Author process design specifications and validation project plans
·  Author process development / process validation protocols and reports
·  Author investigational / technical study protocols and reports
·  Support project team in the execution of technical studies and development/validation protocols
·  Assist in the generation of project schedules with project leader
·  Contribute to product submission documentation and defend studies during regulatory inspections
·  Support project execution logistics including sample and inventory management
·  Support investigations, troubleshooting, CAPA and Change Control activities

The Job Responsibilities Include:

·  Working with different disciplines (Quality, Operations, Regulatory, and Engineering) in the execution of development and validation studies to industrialize processes for Phase II, III and licensed products to assure commercialization of robust, compliant, and efficient processes for vaccines and biopharmaceuticals
·  Participating in programs that use structured methodologies such as Quality by Design, Design Space and Process Control Strategies in the course of industrial process design, validation and control.
·  Supporting project priorities and timelines, and the overall project validation strategy
·  Supporting strategic aspects of validation projects with minimal supervision

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

Basic Qualifications:

·  Bachelor of Science Degree in an Engineering or Science discipline
·  2-5 years of experience in process development / validation (formulation, filling, lyophilization)

Preferred Skills:

·  Strong technical writing and verbal communication skills
·  eDoc, SAP, Trackwise, Phenix, LIMS proficiency

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.

#GD-SP

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.