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Senior Process Validation Engineer -Swiftwater,PA

Swiftwater, Pennsylvania

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Overview

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.

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

Role / Posting Job Title: Senior Process Validation Engineer

HR Job Position Title: Manager Senior Process Engineer, Manufacturing Technology

Industrial Operations, Swiftwater, Pennsylvania, USA

Who We Are

Industrial Affairs (IA) 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 IA 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 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 bio-pharmaceuticals.
  • 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.

Who You Are

Sanofi Pasteur’s IA 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). 

Basic Qualifications

Bachelor of Science Degree in Chemical or Mechanical Engineering

5 - 10 years of experience in filling equipment qualification / filling process development and validation

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

Preferred Skills:

Strong technical writing skills

Ability to coach junior staff members

eDoc, SAP, Trackwise 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.

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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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