Computer System Validation (CSV) Specialist (EBR System)

Pinnaql • Guaynabo, PR

2d • Onsite

About The Position

Validation & Engineering Group, Inc. (V&EG) is seeking a talented and dedicated Computer System Validation (CSV) Specialist to work on an Electronic Batch Record (EBR) / EVRS implementation project. The primary goal is to validate and support the system to ensure it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements. The scope of work involves developing and executing CSV deliverables for EVRS modules that manage recipes, master batch records, and batch execution. This includes confirming system requirements, performing risk assessments, and ensuring traceability for critical data elements like electronic signatures, audit trails, and change control. The role also entails vendor/system assessments, GAP analysis, mapping to regulatory controls, and creating/executing various validation artifacts such as URS, VRA, DQ/IQ/OQ/PQ, test scripts, and validation summary reports. Support will be provided for configuration, data migration, user acceptance testing, and defect closure. The specialist will also assist during go-live, initial production batches, and the handover to QA/IT. Deliverables include a validation project plan, RTM, risk assessment, qualification reports, test scripts, data migration verification, validation summary report, SOP reviews, and training materials, along with post-implementation support.

Requirements

• CSV specialist with 5+ years experience validating EBR/EVRS systems in regulated pharma/biotech/medical devices.
• Experience with 21 CFR Part 11, EU Annex 11, GMP, and applicable GCP/GLP as needed.
• Hands-on experience writing/executing IQ/OQ/PQ and creating traceability matrices.
• Experience with recipe management, MES/SCADA/ERP integrations, and data migration for master recipes.

Nice To Haves

• Computer science/engineering or life-science degree
• Certification(s) such as ASQ, ISPE, or vendor-specific EVRS experience.

Responsibilities

• Develop/execute CSV deliverables for EVRS modules that manage recipes (formulas), master batch records, and batch execution.
• Confirm system requirements, risk assessment, and traceability for recipe data, electronic signatures, audit trails, and change control.
• Perform vendor/system assessments, GAP analysis, and mapping to regulatory controls.
• Create/execute validation artifacts: URS, VRA, FRS/SRS (if applicable), DQ/IQ/OQ/PQ (or equivalent), test scripts, test execution results, traceability matrix, validation summary report.
• Support configuration, data migration/verification of recipe records, user acceptance testing, and remediation/defect closure.
• Provide CSV support during go-live and initial production batches, and handover to QA/IT for periodic review.
• Deliverables: Validation project plan and schedule, Requirements traceability matrix (RTM), Risk assessment (e.g., FMEA/Hazard analysis for recipes), Design qualification (DQ) report, Installation qualification (IQ) procedures & reports, Operational qualification (OQ) procedures & reports (including negative/edge cases for recipe execution), Performance qualification (PQ) scripts & reports (including sample batch runs), Test scripts and executed test evidence, incl. electronic signature and audit trail verification, Data migration plan and verification evidence for recipe/master records, Validation summary report and final sign-off package, SOP/Work instruction reviews and CSV-related training materials, Post-implementation validation support.

Benefits

• People always come first.
• Empowered to do your best work.
• Opportunity to make a meaningful difference by shaping the future of healthcare and technology.
• Purpose-driven, supportive team.
• Equal opportunity employer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED