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Sanofi Group Validation Engineer III in Framingham, Massachusetts

The Validation Engineer III 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: DQ, IQ, OQ, PQ, CQ, RQ, etc.

Essential Duties and Responsibilities:

  • Generates and executes CQV protocols for facilities, utilities, equipment (e.g. Autoclaves, Chambers, Rooms, HVAC, etc.), and computerized systems (e.g. Delta V, HPLCs, Spectrophotometers, etc.)

  • Performs basic data and statistical analysis (e.g. Temperature, Pressure, etc.)

  • Generates complex CQV plans, traceability matrices, and qualification/technical reports

  • Generates and 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 and revises Validation SOPs

  • Generates change controls, performs validation expert assessments

  • Performs validation risk-assessments

  • Manages or oversees validation projects which may involve defining validation scope, risk assessments, strategy, validation plan, and validation schedule

  • Provides validation training to team members

EDUCATION:

  • Bachelors in STEM field (Preferred) and approximately 6+ years of relevant experience

  • Masters in STEM field (Preferred) and approximately 4+ years of relevant experience

SUPERVISORY RESPONSIBILITIES:

  • Minimal oversight of contingent and managed service workers

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 Deviation

  • Previous training and practical knowledge of cGMP regulations

  • Previous training/knowledge on current risk-based validation approaches

  • Experience with data acquisition systems (e.g. Kaye Validator, ELLAB, Lives International, etc.)

SKILLS:

  • Proficient with MS Office Word and Excel

  • Excellent oral and written communication and presentation skills

  • Good organizational and time management skills

  • Ability to manage small to large projects and lead teams

  • 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

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.

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