Overview
Senior Validation Specialist position at our Irvine site. As a Validation Specialist, you will be responsible for performing all validation activities related to the Irvine site, both routine and project related. Your key responsibilities will include:
* Generate and ensure accuracy of validation protocols before execution.
* Plan and coordinate the execution of validation protocols.
* Collate and evaluate data from executed protocols; generate and approve summary reports.
* Generate or approve Quality Risk Assessment documents related to validation activities.
* Investigate and resolve deviations, raising CAPAs as necessary.
* Participate in change control and risk evaluation activities related to validation.
* Provide progress updates and reports to the Validation Supervisor.
* Lead small multi-disciplinary teams as needed.
* Interact with customers to understand and meet validation requirements.
* Serve as a Subject Matter Expert during internal, customer, and regulatory audits.
* Drive Continuous Improvement initiatives for product quality and regulatory compliance.
* Engage in EHS activities, promoting safety and environmental awareness, and manage Risk Assessments.
* Participate in Capital Expenditure initiatives as a validation subject matter expert.
Who You Are
* Degree with a minimum of 5 years of validation experience in equipment and systems.
* GMP experience would be highly advantageous.
* Ability to lead and collaborate with multi-disciplinary teams.
* Commitment to safety and environmental awareness.
* Project management experience is ideal.
* Willingness to travel occasionally for global assignments.
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