This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.
The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes, and equipment for the manufacture of drug substances and/or Drug Product Vaccines and will review and approve validation-related studies for assigned areas.
These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment, and Facility Qualification, and Validation Risk Management.
This position has signatory responsibilities for validation/qualification documents within assigned areas.
Candidates should have some knowledge of biotech manufacturing processes (i.e. viral antigen or formulation production).
Excellent communication skills and teamwork are a must, as an individual will be working on cross-functional project teams which include members from various organizations within Sanofi Pasteur such as Manufacturing Technology, Engineering, and Regulatory Affairs.
Good interpersonal and influencing skills are important for a candidate’s success in this role.
Bachelor’s degree in Engineering, Science, or related field with 0-2 years experience preferably in a cGMP environment.
**Manager Quality Validation – Entry Level**
**Open to recent grads and seasoned applicants**
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.
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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