Validation Engineer III

Framingham, Massachusetts
Industry: Database Administrator / Engineers
Job Number: JN -062021-65747

Description:

  • 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 qualification protocol deviations and non-conformances.


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