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Sr. Instrument Qualification/Computer System Validation Engineer

Foster City, CA · Biotech/Pharmaceutical
Title: Sr. Instrument Qualification/CSV Engineer

Type of role: Contract, 1-2+ Years

Location: Foster City, CA

Our direct client is seeking a Sr. Validation Engineer who has a solid experience on laboratory instrumentation as well as CSV. 
  • Responsible for planning, scheduling, and executing validation efforts for LabX system.
  • Ensures validation is being performed per established procedure, review validation documentation, and coordinating between direct groups for the same.,
  • Identify intended use of laboratory instrument, develop qualification deliverables per current procedure and standards, and coordinate validation  activities between vendor, cross functional teams and users.
  • Communicate to different stakeholders and management on the progress of validation efforts
  • Work with project team for identifying the activities of project, dependencies, and figure out future enhancements.
  • Thorough understanding of FDA and EU guidelines for validation including GAMP, Data Integrity, and AQS
  • Hands on working knowledge of Trackwise, Veeva Vault, and other compliance systems.
  • Execute protocols or peer review protocols depending on the level of access required for execution.
  • Support the routing and accurate documentation of all Change Management, Deviation and Corrective Actions Preventative Actions (CAPAs).
  • Assist in Performing Risk and Impact assessment for validation activities and change requests.
  • Support Data Integrity Assurance Program for all documentation managed by their team.
Dawn West
AdeptSource
 
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