Sr Validation Engineer

Sr Validation Engineer

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 Gilead 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