Fily Saenz
Validation Technician Senior
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Sobre mí
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.
Experiencia
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
Educación
Bachelor's degree in Customs Administration
