Sanofi Group Manager Process Engineer in Swiftwater, Pennsylvania

This position, Manager Process Engineer, within the Manufacturing Technology (MTech) function of Vaccines Industrial Affairs performs activities supporting the development of prefilled-syringe combination products 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:

KEY ACCOUNTABILITIES:

  • Author Design Control documentation to support the development of pre-filled syringe combination products.

  • Author process development / process validation protocols and reports

  • Support project team in the execution of technical studies and development/validation protocols

  • Works closely with cross-functional team to assure project success

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

  • Support investigations, troubleshooting, CAPA and Change Control activities

THE JOB RESPONSIBILITIES INCLUDE:

  • Executes combination product development activities on time, in scope, and within budget with responsibilities to identify development items to meet the intended use and defined user needs of the combination product.

  • Generates documentation needed to support design inputs, design outputs, qualification activities, and regulatory requirements.

  • Participates in combination product risk management activities to identify areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions

  • Assures work activities are conducted in a manner compliant with all applicable regulations, industry standards, Sanofi Pasteur policies. Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.

  • 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

Basic Qualifications:

  • Bachelor of Science Degree in an Engineering or Science discipline

  • 2-5 years of cGMP or Pharmaceutical experience and 1+ years’ experience in the medical device industry

  • Experience in the development of regulated medical devices or combination products under Design Control (21 CFR Part 4 and/or 21 CFR 820) and ISO 14971

  • Strong technical writing skills

Preferred Skills:

  • Experience in process development / validation (formulation, filling, lyophilization, inspection)

  • Excellent Interpersonal Communication Skills

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

#LI-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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life