Key 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 (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 Operating Procedures) to ensure all activities are properly documented and compliant with regulatory requirements.




• Ensure the traceability and audit readiness of all validation activities, supporting internal audits and regulatory inspections.
• Support the creation and review of regulatory filings and submissions as required.
• Ensure proper documentation practices, maintaining the highest standards for data integrity and quality assurance throughout the validation process.
• Actively participate in continuous improvement efforts within the manufacturing area to optimize equipment performance, reduce waste, and enhance operational efficiency.
• Provide training and mentorship to junior engineers or technicians, guiding them through validation protocols, equipment troubleshooting, and best practices.
• Contribute to lessons learned meetings and share insights to improve future validation processes.
• Lead and manage validation projects from conception through to completion, ensuring all aspects of the project adhere to defined timelines, budg

📌 Validation Specialist (México)
🏢 Synstack Technologies
📍 México