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Deputy Director Sterilization Engineering

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

Overview

The Sterilization Engineering Platform Lead is responsible for being a subject matter expert for sterilization, decontamination & depyrogenation at the Swiftwater, Pa Site.  This individual is responsible for ownership of site programs for development and qualification of sterilization, decontamination and depyrogenation processes.  This individual will be a team leader responsible for people development and be responsible for regulatory defense of the methodologies, engineering science and processes utilized across the campus. 

Key Accountabilities

  • Continuous improvement of sterilization, decontamination and depyrogenation qualification programs to be compliant with global quality guidelines, world heath agency regulatory requirements, and cGMP industry guidance documents.  This includes the generation, revision, and review of the program thru procedures.
  • Represent the program during regulatory audits and ensure accuracy of regulatory submissions for sterilization related information.
  • Lead and develop Sterilization Engineering team by resource allocations, performance measurement and budget adherence. 
  • Provide Subject Matter Expert (SME) assistance to licensed production areas.
  • Lead global team of sterilization SMEs to promote best practices between sites.
  • Drive progress and quality through innovative methodologies.
  • Institution of training programs to utilize operators and maintenance technician for Sterilization related development and qualification.
  • Safety:  Ensure team adheres to all site and building safety requirements and procedures and promotes a safety first culture.

Core Competencies

Act for Change

Commit to Customers

Cooperate Transversally

Strive for Results

Develop People

Lead Teams

Think Strategically

Make Decisions

Education/experience

  • Requires a Bachelor’s Degree in Engineering, Microbiology, or other scientific discipline.
  • 10+ years of experience in a cGMP environment preferably in the pharmaceutical sector:  parental drugs: injectables or vaccines.  Experience must include SIP of aseptic filling and support to licensed manufacturing areas.
  • Demonstrated leadership skills including project and / or team leader with direct reports.
  • Demonstrated expert level of knowledge of and experience with sterilization & decontamination methods such as, but not limited to the development and qualification of:  moist heat, dry heat, VHP systems, gamma irradiation, & EtOH.
  • Must have strong communication skills and the ability to effectively work with other functional departments within the organization.
  • Must be able to establish strong working relationships with Site Quality Operations and project execution resources to ensure high quality deliverables meeting GMP and site quality requirements.

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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