Senior Computer System Validation Specialist

Pinnaql, Inc.; Aguadilla (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

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

The role covers reviewing architecture, supplier docs, and SDLC evidence to define validation approaches and close gaps. The candidate will develop, revise, execute, and close validation plans, UDS, FDS, TRMs, and CSV reports, ensuring closed-loop traceability and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering or related field.
• Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed.
• Prior experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Working knowledge of GMP regulations, GDP, regulatory guidance, data integrity, risk-based qualification and validation, and FDA cGMP requirements.

Responsibilities

• Review the system documentation, qualification boundary, and test strategy.
• Develop, revise, execute, and close IQ/OQ protocols and related validation documents.
• Execute validated testing and manage deviations with traceability.
• Ensure changes/releases are governed through Change Control and release readiness activities.
• Assemble the qualification package including IQ/OQ, TRACEABILITY MATRIX, and SRR.

Skills

GxP validation

Documentation writing

Test execution

Communication

Education

Bachelor's degree in Engineering

Job description

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

The role covers reviewing architecture, supplier docs, and SDLC evidence to define validation approaches and close gaps. The candidate will develop, revise, execute, and close validation plans, UDS, FDS, TRMs, and CSV reports, ensuring closed-loop traceability and regulatory compliance.