Fily Saenz

Bachelor's degree in Customs Administration with over four years of experience in the FDA-regulated medical device industry. Proven expertise in manufacturing process validation (IQ/OQ/PQ) and equipment implementation, ensuring 100% compliance with regulatory and document control procedures. Highly skilled in utilizing ERP systems, specifically JD Edwards, Ariba, and Planisware, to manage procurement, purchase orders, and supplier relationships with a high level of accuracy and attention to detail.

Strong analytical and problem-solving professional with a track record of cross-functional collaboration to meet deadlines in dynamic production environments.

Validation Technician Senior at Biosense Webster a Johnson & Johnson Company (2021-12 – Present)

• Planning and delivery of stations for capacity increase projects
• Executed validation documentation (IQ/OQ/PQ) for equipment and new production lines, strictly adhering to ISO Class 8 Clean Room standards and FDA regulations
• Managed supplier relationships for procurement, facilities and layout planning and installation of equipment/ fixtures, as well as implementation with Clean Room ISO Class 8 considerations
• Collaborated with external suppliers for facility planning and equipment installation, overseeing inventory follow-up and layout implementation
• Streamlined the procurement process by managing purchase orders and tenders
• Ensure compliance with document control procedures and regulatory requirements
• Execution of preventive maintenance for the validation of equipment
• Implementation of new production lines with capacity 2389 ea
• Managed end-to-end procurement processes using JD Edwards and Ariba, maintaining high accuracy in purchase orders, tenders, and financial reporting
• Coordinated with Quality, Engineering, and Logistics teams to resolve project bottlenecks, ensuring the timely delivery of stations for capacity increase projects

Immigration process advisor at Visas 44 (2020-01 – 2021-12)

• Assist clients with immigration forms and applications
• Schedule appointments and review documents
• Provide customer service and guidance throughout the process
• Archive documentation and manage the cash register

Bachelor's degree in Customs Administration