Orange County Metro Area, California
The Validation Sr. Engineer will primarily be responsible for developing and executing validation plans and protocols for cleanrooms, cleanroom utilities and equipment across all qualification activities for complex systems and product line assemblies, ensuring that assigned projects are completed in a timely manner and in accordance with company s and external regulatory standards. A key element of this role will be to collaborate with project stakeholders to ensure integrity of the validation process and the timely resolution of issues.
1.Develop validation plan for assigned projects. Draft and execute validation protocols and associated reports to ensure compliance to standards and timely completion. Provide direction for technicians supporting validation execution. Work cross-functionally to gain stakeholder buy-in.
2.Proactively communicate status of assigned projects to key project stakeholders and management. Accountable for troubleshooting, problem solving, and escalating issues to management which may increase project risk. Coordinate or lead issue resolution for missing validation pre-requisites.