Data Integrity & Csv Validation Specialist – Risk Assessments
Jc Automation Corp
- Puerto Rico
- Permanent
- Full-time
JC Automation is a global management and technology consulting firm dedicated to empowering organizations across various industries. We specialize in IT, automation, and regulatory compliance solutions, providing ongoing support through both on-site and remote services to ensure seamless system performance and compliance.Job SummaryWe are seeking a Data Integrity & CSV Validation Specialist to support risk assessments, validation, CAPAs, investigations, and compliance activities for computerized and automated systems in a regulated environment.This role is ideal for professionals with experience in CSV lifecycle, Data Integrity assessments, periodic reviews, EBR initiatives, laboratory systems, and validation documentation support.Key Responsibilities
- Manage validation activities for in-house computerized and automated systems
- Support Laboratory, Sterile, Non-Sterile, and Utilities/Facilities operations
- Execute and close CAPAs, investigations, and Data Integrity assessments
- Manage the Computerized Systems Periodic Review Program
- Support CSV lifecycle documentation, routing, execution, and closure
- Drive continuous improvement initiatives including paperless validation and time reduction
- Support EBR, laboratory analytical instruments upgrades, and CSV IT compliance projects
- Computer System Validation (CSV)
- Data Integrity risk assessments
- CAPA and investigation management
- Computerized systems periodic reviews
- Validation lifecycle documentation
- EBR and laboratory systems
- IT compliance in regulated environments
- English (Preferred)
- Day Shift (Preferred)
- Night Shift (Preferred)
- Overnight Shift (Preferred)
- Manatí Municipio, PR (Required)
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