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Sanofi Group Senior Process Validation Engineer - Vaccines in Swiftwater, Pennsylvania

WHO WE ARE

Sanofi Pasteur is the vaccines division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is located in northeast Pennsylvania and is home to the production of over 140 million doses of vaccine each year.

Manufacturing Technology (MTech) drives the vaccines industrialization and the improvement of processes and products. It embarks on new technologies and digital trends and is the keeper of manufacturing process knowledge. MTech is at the crossroads of R&D and production as the team is spread over 9 production sites.

Close collaboration with R&D to ensure that the processes for new vaccines are as innovative and standardized as possible to guarantee efficacy, cost-effectiveness, and rapid time to market quality vaccines. It is a multi-disciplinary function that provides expertise in the process; manufacturing sciences, process modeling, statistical analysis; process validation, and technology transfer. Commitment and solidarity are key in the MTech department. The Global MTech organization is the seeding ground for technical and scientific talents that execute their work in a large network and offer multiple possible career evolutions. You will be integrated into a team where you will acquire scientific and technical skills, alongside our experts, our data scientists, our project teams, a management team committed to your development. Furthermore, Global MTech is providing cross-functional training and development and is the portal for collaboration with many different organizations including R&D, Manufacturing, Supply Chain, Regulation, and Quality.

THE POSITION

This position of Industrial Affairs Senior Process Validation Engineer, within the Manufacturing Technology (MTech) function of Industrial Affairs, performs activities supporting the development and validation of industrial 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:

  • Serve as a Subject Matter Expert (SME) for filling technologies for existing Drug Products, technology transfers, and new vaccines

  • Drive the technical strategy and project deliverables across the Pharmaceutical Technology (Drug Product) landscape for multiple projects at the Swiftwater site. 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 IA to deliver the following:

Accountabilities:

  • Function as the platform’s prefilled syringe and vial filling SME. Responsibilities within this role include the following as they relate to filling processes:

  • Provide Shop Floor assistance to support investigations, troubleshooting, CAPA and Change Control activities, author/review/approve process design specifications and validation project plans

  • Author/review/approve process development / process validation protocols and reports

  • Author/review/approve investigational and/or technical study protocols and reports

  • Lead teams in the design and execution of technical studies and troubleshooting activities and deliver technical solutions

  • Design and support the execution of Aseptic Process Simulations in RABS and isolators

  • Contribute to product submission documentation and defend studies during regulatory inspections

The Job Responsibilities Include:

  • Having a strong working knowledge of the relationship between filling process parameters, vaccine product characteristics and critical quality attributes.

  • Working with different disciplines (Quality, Operations, Regulatory, and Engineering) in the execution of development and validation studies to industrialize processes for Phase 3 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.

  • Providing technical coaching, training, and guidance to junior engineers on filling related subject matter.

  • Leading tactical responses to process deviations, delivering technical solutions, and communicating outcomes to site management.

  • Keeping up-to-date with and implementing the latest regulatory expectations and industry trends.

EDUCATION AND EXPERIENCE

Basic Qualifications

  • Ph.D. & 2-3 years of experience in the vaccine/biopharmaceutical industry

  • Master's degree and 5 years of experience in the vaccine/biopharmaceutical industry; or

  • Bachelor's degree 8 years of experience in the vaccine/biopharmaceutical industry

  • Strong experience in filling equipment qualification/filling process development and validation

  • Knowledge of the design, operation, and peripheral processes associated with isolator equipment

  • Knowledge of automation process on different filling system

Preferred Skills:

  • Demonstrated expertise in filling (T/P) and peristaltic pump process development

  • Demonstrated expertise in scale down model design and qualification

  • Demonstrated expertise in applying risk-based approaches and QbD/DOE principles

  • Skilled in the transfer of early phase clinical manufacturing processes from R&D to Industrial Operations: including the writing of protocols, reports, BPRs, and technology transfer documents

  • Demonstrated skills in leading small technical teams

  • Demonstrated strong communication (oral and written), interpersonal and interdisciplinary skills.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.

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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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