Sr. Instrument Qualification/Computer System Validation 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.