Principal Investigator - Vaccine

Principal Investigator - VaccineThis is a 1st shift position.This position is within the Antigen Quality Systems group and will support Biologics Manufacturing by completing deviation investigations.The candidate will work cross-functionally with Operations and various support groups to implement effective and preventative actions as well as perform a thorough product impact assessment.KEY ACCOUNTABILITIES:Authoring and resolution of deviations, change controls, CAPAs, or documents in order to meet production and product release requirements.Identification and facilitation of interdepartmental process improvements.Utilize root cause analysis techniques during deviation investigational processWork cross-functionally, to develop and implement continuous process improvementsSupport production needs and continuous improvement including change control, deviation writing/review, CAPA implementation, and operational optimization.Collaboration with Technical Writers to write, review, revise and prepare manufacturing documents (BPR, SOP, SWI) in accordance with cGMP and regulatory municate across multiple groups and levels to obtain consensus in order to facilitate deviation closureManage multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of the organizationAccurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.BASIC QUALIFICATIONS:High School Diploma and 3+ years cGMP experience.Associates Degree and 2+ years cGMP experienceBachelors degree and 1+ years cGMP experiencePREFERRED QUALIFICATIONS:Must have knowledge of continuous improvement techniques and problem-solving skills.Previous experience working within a production department of a pharmaceutical company preferred.The candidate must be able to work extended and flexible hours (including weekends) when needed.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.GD-SPLI-SPAt 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.

Created: 2025-10-04