CSV Specialist: Master GxP Validation & Risk‑Based Testing

Validation & Engineering Group, Inc.; Isabela N00207-Air Base (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. (VEG) seeks a Computer System Validation Specialist to provide risk-based validation services for GxP computerized systems.

The role includes reviewing intended use, architecture, documentation, and data flows to define the validation approach and plan lifecycle activities. You will develop, revise, execute, and close validation documents, perform IQ/OQ testing, ensure change control governance, and document evidence.

Qualifications

• Bachelor's degree in Engineering or related field.
• Hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or GxP environments.
• Working knowledge of GMP, GDP, FDA cGMP requirements, and ISPE/GAMP principles.
• Ability to interpret specifications, design documents, and vendor documents.
• Proven ability to write qualification or validation documents and reports.
• Strong written and verbal English; Spanish preferred.

Responsibilities

• Review User Requirements Specifications, design documents, vendor manuals, commissioning records, and other lifecycle documents.
• Confirm qualification boundary, components, prerequisites, test strategy, acceptance criteria, and needed documentation.
• Perform field walkdowns and reviews to confirm readiness for qualification.
• Generate an IQ/OQ protocol using Company procedures and document control.
• Incorporate review comments and route protocol for approval.
• Execute IQ/OQ per procedures and GDP; capture objective evidence.
• Document discrepancies and deviations; provide information for resolution.
• Coordinate retesting after corrective actions within scope and hours.
• Assemble protocol and evidence into a complete package for review.
• Generate and maintain Requirements Traceability Matrix.
• Generate Qualification Summary Report with scope, results, deviations, and conclusions.
• Support review resolutions and final approvals of artifacts.
• Maintain weekly forecast, deliverable tracker, and time records.

Skills

GxP validation

IQ/OQ protocols

Test execution

Documentation practices

Risk assessment

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. (VEG) seeks a Computer System Validation Specialist to provide risk-based validation services for GxP computerized systems.

The role includes reviewing intended use, architecture, documentation, and data flows to define the validation approach and plan lifecycle activities. You will develop, revise, execute, and close validation documents, perform IQ/OQ testing, ensure change control governance, and document evidence.