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Principal Validation Engineer

Company: Sanofi
Location: Framingham
Posted on: September 19, 2022

Job Description:

The Principal Validation Engineer leads and performs Commissioning, Qualification, and Validation (CQV) activities in support of early phase cGMP clinical manufacturing, fill-finish, and QC laboratories. This individual assures validation activities are performed in accordance with applicable Standard Operating Procedures (SOPs), Sanofi standards, industry best practices, and regulatory requirements. The individual performs validation program-related activities such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Change Qualification (CQ), Requalification (RQ), etc. ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Generates, executes, reviews/approves CQV protocols for facilities, utilities, equipment (e.g. Autoclaves, Chambers, Rooms, HVAC, etc.), and computerized systems (e.g. Delta V, High-Performance Liquid Chromatography (HPLC), Spectrophotometers, etc.)
  • Performs and reviews data and statistical analysis (e.g. Temperature, Pressure, etc.)
  • Generates complex CQV plans, traceability matrices, and qualification/technical reports
  • Generates and reviews/approves qualification protocol deviations and nonconformances
  • Reviews and approves vendor-generated computer system qualification protocols/packages
  • Generates quality deviations/CAPAs and performs investigations and root cause analysis
  • Generates, revises and approves Validation SOPs
  • Generates change controls, performs validation expert assessments
  • Performs and reviews/approves validation risk-assessments
  • Manages or oversees validation projects which may involve defining validation scope, risk assessments, strategy, validation plan, and validation schedule
  • Provides mentoring and training to Validation team members BASIC QUALIFICATIONS:
    • Bachelor s degree in engineering/science and 10+ years of relevant experience, or
    • Master s degree in engineering /science and 8+ years of relevant experience. PREFERRED QUALIFICATIONS:
      • Expert knowledge of risk-based commissioning, qualification, and validation approaches that meet current regulatory requirements, internal standards, and industry practices
      • Ability to read/interpret engineering drawings and design documents.
      • Demonstrated ability to manage medium to large size Commissioning, Qualification, and Validation (CQV) projects.
      • Strong mentoring and development experience is required.
      • Must be able to establish strong working relationships with stakeholders to ensure high-quality deliverables meeting cGMP and site quality requirements.
      • Subject Mater Expert in facility, utility, and equipment commissioning and qualification.
      • Knowledge of computer system validation SKILLS:
        • Proficient with MS Office Word, Excel, Project, and PowerPoint
        • Excellent oral and written technical writing, communication, and presentation skills
        • Good organizational and time management skills
        • Self-motivated, able to work independently, and work in a team environment CERTIFICATES, LICENSES, REGISTRATIONS:
          • None Required PHYSICAL DEMANDS:
            • May require some travel; less than 5%
            • Ability to lift up to 20lbs
            • Ability to stand for prolonged periods of time
            • Must be able to work in a controlled classified environment while wearing personal prospective equipment/gowning 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. Fully vaccinated, 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.

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

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