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Computer System Validation Specialist
Validation & Engineering Group, Inc.. Provide risk-based validation services for Factorian, L7 ESP, and other GxP computerized systems .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in risk-based validation and qualification protocols within GxP environments, with a strong focus on compliance with GMP regulations and effective documentation practices. Proficient in executing and managing validation lifecycle documents and testing in computerized systems.
Highest-signal resume keywords
Risk-Based ValidationQualification Protocol DevelopmentGxP ComplianceGMP Regulations KnowledgeStrong Written Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Validation PlansTest ProtocolsRisk AssessmentsTraceability MatricesDiscrepancy RecordsIQ/OQ ProtocolsData Integrity PrinciplesUser Requirements SpecificationsChange ControlCSV Lifecycle Documents
Soft Skills
Strong Verbal CommunicationIncident ManagementProblem Resolution
Industry Keywords
GxP Computerized SystemsFDA cGMP RequirementsEU GMP Annex 121 CFR Part 11ISPE/GAMP PrinciplesGood Documentation PracticesPharmaceutical IndustryBiologicsRegulatory GuidanceField Walkdowns
Tech Stack
Tools & technologiesSDLC
About the role
Key responsibilities & impact- Provide risk-based validation services for Factorian, L7 ESP, and other GxP computerized systems
- Review intended use, GxP impact, system architecture, supplier documentation, configuration, customization, interfaces, data flows, infrastructure dependencies, and SDLC evidence
- Define validation approaches and identify gaps
- Develop, revise, execute, and close lifecycle documents, including assessments, validation plans, specifications, risk assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
- Evaluate and test controls for access, roles, permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time 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
- Govern changes and releases through Change Control and confirm validation, procedural, training, data, and operational readiness before release
- Review qualification documents and supporting records
- Confirm qualification boundaries, components, prerequisites, test strategy, acceptance criteria, and documentation requirements
- Perform field walkdowns and document reviews
- Generate, route, execute, and close IQ/OQ protocols
- Document discrepancies, exceptions, and deviations and support resolution
- Assemble executed protocols and evidence packages
- Generate Requirements Traceability Matrices and Qualification Summary Reports
- Support review comment resolution and final approvals
- 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- Equal opportunity employer
- Supportive, purpose-driven team environment
- Opportunity to make a meaningful difference in healthcare and technology
- Authorized remote work for development and testing activities
- Company-provided procedures, templates, and document control process