Sr Validation  Engineer

Sr Validation Engineer

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.