Senior CSV Specialist – Computer System Validation

Veg Group; Aguadilla (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Computer System Validation Specialist to deliver risk-based validation services for GxP computerized systems including Factorian and L7 ESP.

You will review requirements, architecture, and supplier docs to define validation strategies and create IQ/OQ protocols. Responsibilities include executing validated testing, maintaining traceability, managing deviations, and coordinating corrective actions.

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 comparable GxP environments.
• Familiarity with GMP regulations, GDP, 21 CFR Part 11, FDA cGMP and ISPE/GAMP principles.

Responsibilities

• Review user requirements, system architecture, vendor documentation, and qualification boundary.
• Develop and execute IQ/OQ protocols and support protocol routing until approval.
• Perform testing, capture traceable evidence, document deviations, and coordinate retesting.
• Ensure changes and releases are governed through Change Control and release readiness.

Skills

Clear communication skills

English proficiency

Spanish preferred

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. seeks a Computer System Validation Specialist to deliver risk-based validation services for GxP computerized systems including Factorian and L7 ESP.

You will review requirements, architecture, and supplier docs to define validation strategies and create IQ/OQ protocols. Responsibilities include executing validated testing, maintaining traceability, managing deviations, and coordinating corrective actions.