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Validation Engineer III

Company: Sanofi
Location: Framingham
Posted on: June 25, 2022

Job Description:

ESSENTIAL DUTIES AND RESPONSIBILITIES:Generates and executes CQV protocols for facilities, utilities, equipment (e.g. Chambers, Rooms, etc.), and computerized systems (e.g. High-Performance Liquid Chromatography (HPLC), Spectrophotometers, etc.) for GLP equipment in Cambridge and Framingham, MAPerforms basic data and statistical analysis (e.g. Temperature, Pressure, etc.)Generates complex CQV plans, traceability matrices, and qualification/technical reportsGenerates and approves qualification protocol deviations and nonconformancesReviews vendor-generated computer system qualification protocols/packagesGenerates quality deviations/CAPAs and performs investigations and root cause analysisGenerates and revises Validation SOPsGenerates change controls, performs validation expert assessmentsPerforms validation risk-assessmentsManages or oversees validation projects which may involve defining validation scope, risk assessments, strategy, validation plan, and validation scheduleProvides validation training to team membersBASIC QUALIFICATIONS:Bachelors in STEM field (Preferred) and approximately 6 years of relevant experience; orMasters in a STEM field (Preferred) and approximately 4 years of relevant experiencePREFERRED QUALIFICATIONS:Experience with data acquisition systems (e.g. Kaye Validator, ELLAB, Lives International, etc.)Experience performing CQV activities for chambers, rooms, autoclaves, bioreactors, utilities (e.g. WFI, Clean Steam, Compressed Air, etc.), HVAC, benchtop laboratory equipment, etc.Previous training on cGMP quality systems such as Change Control, CAPA, and DeviationPrevious training and practical knowledge of cGMP regulationsPrevious training/knowledge on current risk-based validation approachesExperience with data acquisition systems (e.g. Kaye Validator, ELLAB, Lives International, etc.)SKILLS:Proficient with MS Office Word and ExcelExcellent oral and written communication and presentation skillsGood organizational and time management skillsAbility to manage small to large projects and lead teamsSelf-motivated, able to work independently, and work in a team environmentCERTIFICATES, LICENSES, REGISTRATIONS:None RequiredPHYSICAL DEMANDS:Will require travel between Cambridge and FraminghamAbility to lift up to 20lbsAbility to stand for prolonged periods of timeMust be able to work in a controlled classified environment while wearing personal prospective equipment/gowningAs 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-SGLI-GZPDNAt 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.PDN-967128bf-5201-4c09-b93a-9d0d676b2cf7

Keywords: Sanofi, Framingham , Validation Engineer III, Engineering , Framingham, Massachusetts

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