Computer System Validation Specialist

Validation & Engineering Group, Inc.

. Provide risk-based validation services for Factorian, L7 ESP, and other assigned GxP computerized systems .

Posted 9/30/2026full-timeAguadilla • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in risk-based validation and qualification of GxP computerized systems, with a strong focus on compliance with GMP regulations and effective documentation practices. Proficient in developing and executing validation protocols and lifecycle documents while ensuring data integrity and adherence to industry standards.

Highest-signal resume keywords

Risk-Based ValidationQualification Protocol DevelopmentGxP ComplianceGMP Regulations KnowledgeStrong Written Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlansTest ProtocolsRequirements Traceability MatricesRisk AssessmentsSupplier AssessmentsData Integrity PrinciplesChange ControlUser Requirements SpecificationsExecution of TestingDiscrepancy Documentation

Soft Skills

Strong Verbal CommunicationAttention to Detail

Industry Keywords

GxP EnvironmentsFDA cGMP RequirementsEU GMP Annex 121 CFR Part 11ISPE/GAMP PrinciplesGood Documentation PracticesRegulatory GuidanceField WalkdownsCalibration RecordsCommissioning Evidence

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Provide risk-based validation services for Factorian, L7 ESP, and other assigned GxP computerized systems
Review intended use, GxP impact, system architecture, supplier documentation, configuration, customization, interfaces, data flows, infrastructure dependencies, and existing SDLC evidence
Define validation approaches and identify gaps
Develop, revise, execute, and close lifecycle documents including assessments, validation plans, specifications, risk assessments, supplier assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
Evaluate and test controls for access, permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, synchronization, backup and recovery, migration, security, and administration
Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain traceability through closure
Ensure system changes and releases are governed through Change Control and that validation, procedural, training, data, and operational readiness activities are complete
Review qualification documents and evidence for assigned systems or equipment
Confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and documentation requirements
Perform field walkdowns and document reviews
Generate, route, execute, and support approval of IQ/OQ protocols
Document discrepancies, exceptions, and deviations and provide technical information for resolution
Assemble executed protocols and supporting evidence into complete approval packages
Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
Maintain weekly forecasts, deliverable trackers, and time records

Requirements

What you’ll need

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 applicable GMP regulations, Good Documentation Practices (GDP), regulatory guidance, data integrity principles, risk-based qualification and validation, and relevant industry standards
Knowledge of FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles
Ability to interpret User Requirements Specifications, design documents, drawings, functional specifications, control narratives, vendor documentation, calibration records, and commissioning evidence
Demonstrated ability to write clear qualification or validation documents and reports
Ability to execute testing accurately in the applicable field or computerized environment
Strong written and verbal communication skills in English
Spanish proficiency preferred for effective site interaction

Benefits

Comp & perks

Empowered, supportive, purpose-driven team environment
Equal opportunity employer