Computer System Validation Engineer

The Computer System Validation (CSV) Engineer will support the validation, testing, and documentation of computer systems to ensure compliance with regulatory and quality standards, collaborating with IT, quality, and operations teams to maintain validated systems and data integrity.

Work Details:

• Environment: Medical Device / CSV / Quality IT Systems
• Location: Juncos, Puerto Rico
• Work Arrangement: Full-time, 100% on-site

• Education Required: Bachelor’s Degree in Engineering
• Experience Required: 4-6 years in regulated environments
• Must be Bilingual: Spanish/English
• Computer System Validation (CSV) and IT systems knowledge in regulated environments.
• Experience preparing and managing validation documentation, SOPs, and change controls.
• Understanding of federal and international regulations governing computerized systems (e.g., FDA 21 CFR Part 11, ISO 13485, EU Annex 11).
• Quality and compliance leadership, including guiding peers and cross-functional teams.

• Conduct compliant validation processes for quality IT systems, including preparation of formal documentation such as SOPs, validation protocols, and reports.
• Coordinate validation activities with clients, developers, IT personnel, and operational teams, both domestic and global if applicable.
• Identify requirements for compliant computerized operations and recommend implementation and maintenance of procedures to assure compliance.
• Monitor regulatory changes and ensure validation practices remain up to date with federal and international requirements.
• Perform system administration and configuration of quality IT systems.
• Report on validation activity status to fulfill regulatory and internal quality requirements.
• Support audits and regulatory inspections by ensuring all validated systems and documentation are compliant.

• Paid time off
• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Employee assistance program
• Employee discount
• Professional development (certifications, courses & assistance)
• Referral program

*Please note that this is a long-term position and requires 100% on-site presence in Juncos, Puerto Rico.*