Validation Specialist

Responsibilities

• Plan, execute, and manage validation protocols for manufacturing equipment, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure compliance with regulatory standards such as FDA, ISO 13485, etc.
• Lead the qualification of new and existing manufacturing equipment to ensure proper installation, performance, and consistent functionality.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant standards throughout validation processes.
• Provide technical expertise on equipment, ensuring that systems and tools meet necessary specifications, performance criteria, and operational requirements.
• Lead root cause analysis and troubleshooting efforts when equipment issues arise during validation, identifying corrective and preventive actions (CAPA).
• Develop and review validation protocols, reports, and SOPs (Standard...