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Manager - Reliability Engineering Fill & Finish - Vaccine

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

Summary

Manager – Reliability Engineering, along with other members of Technical Services, is responsible of leading, optimizing and implementing Preventive and Predictive Maintenance of process equipment in order to achieve the right maintenance strategy to support the business without compromising safety or compliance.

This position will be responsible of the FFIP (Formulation, Filling, Inspection & Packaging) operation process equipment. The incumbent will oversee, track and troubleshoot daily equipment failures and propose corrective actions in coordination with maintenance team. This position will develop and maintain a strategic equipment Lifecycle master plan for the FFIP operations to ensure process equipment, parts and technology replacement are proactively planned and implemented. It will also participate in the strategic implementation of new equipment, processes improvement, impact assessment of Capital projects associated with the FFIP operations.    

The candidate must possess knowledge of equipment lifecycle analysis, predictive and preventative maintenance strategies for equipment including Formulation skids, Vial/Syringe filling machines, Lyophilizer, Autoclave, Automatic Inspection and Packaging machine.  

The role is expected to be able to identify issues or needs and initiates projects or programs to address them. The candidate shall be able to evaluate minor capital project requests and lead the implementation of the project within site compliance requirements. The individual works collaboratively to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent must be able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.

Major Challenges

  • Provide technical expertise, troubleshooting and improved equipment maintenance/reliability strategies to optimize safe, compliant, and efficient operations of process equipment.

  • Establishes effective preventative and predictive maintenance plans for GMP Pharmaceutical process equipment according to OEM recommendations, industry standards and process application.

  • Manage any CAPAs associated with the CMMS (Computerized Maintenance Management Systems), including PMs or out of conformance Reliability Program

  • Execute criticality and gap assessments for equipment and components

  • Execute FMEA, RCA and identify alterative options to reduce or eliminate risk

  • Role includes conducting detailed investigations to determine root cause and necessary CAPAs by working cross functionally with FFIP, Maintenance, QA, Quality Validation and Technical service Management.

  • Execute Historical trends to evaluate the criticality assessment, FEMA and RCA for periodic review.

  • Reviews completed demand work orders for compliance with change control and like-for-like procedures

  • Conducts Historical Performance Reviews on GMP Direct Impact assets.

  • Strong ability to drive initiatives and influence changes.

  • Maintains a high level of multi-tasking ability in conjunction with proven organizational skills.

  • Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously

  • Adept in Microsoft Office Suite - Word, PowerPoint, MS Project, Excel and Outlook, Visio and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.

  • Ability to effectively communicate with employees, contractors and vendors.

  • Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task

  • Self-starter who is able to work both independently without direct supervision or in a team environment

Education/Experience

  • BS ME/EE/ChE/IE

  • A minimum of 5-10 years of experience in a manufacturing environment, acting in maintenance or engineering capacity to improve equipment operation. 

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

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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