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.