Manager Quality Validation Automation - Vaccines
Swiftwater, Pennsylvania
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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Do you have what it takes for a successful career with Sanofi?
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Culture: Play to Win
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Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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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.
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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.
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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.
Quote
"Working at Sanofi I have a career not just a job."
DAN MOORE
Global Project Manager
"Working here I feel valued and empowered to do my best. I am proud to be part of a team dedicated to driving change to help save the lives of our patients."
RAQUEL REYES
Biological Sales Program
"Working at Sanofi YOU own your career. Where you go is up to you!"
LUCAS GEORGE
Director of Viral Manufacturing - Biologics
Responsibilities
Manager - Quality Validation Automation
(Swiftwater, PA) This position is responsible for providing Quality & Compliance oversight to site Automation Validation projects. This position is responsible for ensuring the site policies and regulatory requirements are followed for Automation projects on site.
Key Accountabilities:
The individual will participate in project teams and will review and approve automation validation related documentation for systems including but not limited to: C+Q, Automated Equipment, RT Reports, criticality assessments, validation plan, user requirements, specifications, UAT, qualification/validation protocols and reports.
Technical competencies:
Knowledge of 21CFR Part 11, Annex 11 and GAMP V
Understanding of GxP regulations and computer validation principals
Understanding of software development lifecycles
Understanding of document management principals
Demonstrated technical writing and oral communication skills.
Scientific education or experience, with test script design, technical document reviews preferred
Knowledge of cGMPs and regulatory requirements Strength in several LEAD Competencies-Think Strategically, Act for Change, Strive for Results, Cooperate
Transversally, Commit to Customers, Make Decisions
Basic Qualifications:
Bachelor’s degree in Engineering, Computers or related field.
5+ years in a GMP regulated environment working on computer system validations
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.
