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Manager, Validation

Pearl River, New York

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Overview

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Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Leadership
  • Proactive
  • Problem-Solver
  • Results-driven
  • Team player

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Culture: Play to Win

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    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

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    Collaboration

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

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

**Monday-Friday- 1st shift**

**Required experience in Validation and Quality**

  • Responsibilities may include but are not limited to: Provide validation leadership for qualification studies associated with the development and implementation of processes, systems, and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions. 
  • Expertise in the following areas are required: Cleaning Validation, Equipment Qualification, Facility/Utilities Qualification, and Process Validation
  • Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process. 
  • Lead validation studies and author the associated documentation with no supervision. 
  • Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects. 
  • Execute development and Performance Qualifications in media preparation, including engineering runs and process validation lots of vaccine products. 
  • Act as subject matter expert (SME) for issues pertaining to these programs.
  • Lead Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.
  • Lead in development of technical and manufacturing documents necessary for development studies, cleaning, sanitization, and sterilization process validation.
  • Provide documented evidence that processes are consistent and reliable through challenges against pre-established criteria. 
  • Provide technical support to help develop and execute project plans; and obtain and analyze relevant data and prepare appropriate reports for regulatory submissions. 
  • Design validation studies, author and approve protocols, and ensure compliance with regulatory requirements, corporate standards and site guidance for validation. 
  • Author or update Validation SOPs,
  • Lead in authoring the Annual Product Review on Validation and Change Control, and Site Validation Master Plan (VMP). 
  • Own development of Validation Assessments for unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence.
  • Must have a strong understanding of risk-and science-based approach to validation and experience with process risk assessments including FMEAs. 
  • Must have Project Management experience.
  • Excellent interpersonal effectiveness and communication skills (written and oral) required to work across departments and management levels. 
  • Ability to function effectively and independently in a fast-paced, dynamic environment. This position has no direct reports.

Education/experience

Bachelor’s Degree in science/engineering or a related field with 8-10 years' of experience in GMP controlled/pharmaceutical environment required, including at least 8 years' of experience in Validation and Quality/Compliance.  MS degree in Engineering preferred

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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