Anfernee Abril
Sabana Grande,Puerto Rico
Summary
Detail-oriented engineer with a computer science background specializing in computer system validation within regulated pharmaceutical environments. Skilled in system lifecycle management, risk analysis, and validation of enterprise systems including LIMS and BMS. Collaborates effectively with product and process engineering teams to ensure compliance and support complex technical systems.
Overview
6
6
years of professional experience
Work History
Computer System Validation
Fresenius Kabi
San German, Puerto Rico
06.2020 - Current
- Validated critical manufacturing, laboratory, and facility systems in regulated environments to support product and process engineering initiatives.
- Execute system lifecycle activities, including: Requirements documentation, Risk assessments, Validation planning, System qualification and verification.
- Develop and maintain validation documentation including: Master Validation Plans (VMP), Design & Configuration Specifications, DIRA / MIRA Risk Assessments, IQ / OQ / PQ Protocols.
- Conduct risk analysis using FMEA and HIRA methodologies to identify system failure modes and implement mitigation strategies.
- Perform validation and qualification activities for facility and infrastructure systems, including Building Management Systems (BMS).
- Support integration of laboratory instruments with LabWare LIMS, ensuring reliable system communication and data integrity.
- Collaborated with process engineers, IT, quality assurance, and manufacturing teams to ensure operational and regulatory requirements were met for validated systems.
- Troubleshoot system integration and configuration issues using technical documentation and root cause analysis.
- Maintained GxP compliance and FDA regulatory standards through implementation of risk-based validation strategies.
Software Developer
CIQA
Hormigueros, PR
01.2020 - 06.2020
- Created well-designed, testable code that ensured high-quality software outputs and met client specifications.
- Developed interactive web products using HTML, CSS, and JavaScript.
- Collaborated with clients to analyze requirements, delivering tailored and functional solutions.
Education
Bachelor of Science (B.S.) - Computer Science
Inter American University of Puerto Rico
San German, PR05.2020
Skills
- LIMS integration
- LabWare LIMS
- Validation planning
- Regulatory Compliance
- System integration
- Instrument integration
- SQL/NoSQL
- JavaScript
- Operating Systems (Windows, Linux)
- Power BI
- Excel
- Analytical Problem-Solving
- Strong Communication
Languages
- English
- Spanish
Timeline
Computer System Validation
Fresenius Kabi
06.2020 - Current
Software Developer
CIQA
01.2020 - 06.2020
Bachelor of Science (B.S.) - Computer Science
Inter American University of Puerto Rico