Process Validation Specialist

Company: Sanofi
Location: Swiftwater
Posted on: April 25, 2025

Job Description:

Job Title: Process Validation Specialist

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSAT fulfils an important function by providing day-to-day Manufacturing Support, focusing on technical and process aspects, effective Life Cycle Management, process robustness enhancement, and yield improvement to optimize performance.

Join our global network and contribute to the launch of 3 to 5 new products annually across various modalities, enabling us to reach and serve more patients and communities. Collaborate with a team of talented and passionate international experts, scientists, and project leaders who are dedicated to inventing, designing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modelling, all in support of Sanofi's best-in-class ambition.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Contributes to define and execute validation strategies through all stages, from basic engineering to industrialization.
  
• Collaborates with cross-functional teams (MSAT, Quality, Operations, Engineering, CMC, Regulatory, HSE) to design and execute development and validation studies for mixing, hold times, filter validation, column packing, and process performance qualification. Control Strategy definition.
  
• Contributes to define regulatory submission strategy and provides support to regulatory team.
  
• Ensures transverse management for successful right first-time delivery across all functions.
  
• Leads validation execution, authors process validation documents, performs data analyses to document and interpret studies results.
  
• Shop-floor support during development and validation studies execution.
  
• Leads risk assessments and investigations for validation protocol deviations and change management activities (change control).
  
• Working understanding of site quality systems supporting document management, change controls, deviations, and CAPAs.
  
• Defends validation documents in internal and external audits.
  About the Job
  
  Requirements:
  
  Experience:
  • 3+ years of experience in a pharmaceutical field. Industrial experience in pharmaceutical projects, including process validation and process development preferred.
    Soft skills:
    • Excellent communication skills and ability to influence project teams.
      Technical skills:
      • Strong knowledge of vaccine processes and cGMPs and regulatory requirements
        
      • Strategic vision to further develop simplification, standardization, digitalization
        
      • Working understanding of validation concepts and requirements
        
      • May be required to gown and operate in classified manufacturing environments
        Education:
        • Bachelor's or Master's Degree in Biotechnology, Life Sciences, Chemical Engineering, or equivalent
          Languages:
          • English
            
            Why Choose Us?
            • Bring the miracles of science to life alongside a supportive, future-focused team.
              
            • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
              
            • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
              
            • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
              
              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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              All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.PandoLogic. Keywords: Quality Control / Quality Assurance Specialist, Location: Swiftwater, PA - 18370 , PL: 597425175

Keywords: Sanofi, Passaic , Process Validation Specialist, Other , Swiftwater, New Jersey