Senior Validation Specialist

Your role: We have an exciting 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.