FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Computer System Validation Specialist
Validation & Engineering Group, Inc.. Provide risk-based validation services for Factorian, L7 ESP, and other assigned 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 of GxP computerized systems, with a strong focus on compliance with GMP regulations and Good Documentation Practices. Proficient in developing and executing qualification protocols, managing documentation, and ensuring data integrity in pharmaceutical environments.
Highest-signal resume keywords
Risk-Based ValidationQualification Protocol DevelopmentGxP ComplianceGood Documentation PracticesFDA cGMP Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Qualification ProtocolsCSV Lifecycle DocumentsValidation PlansTest ProtocolsTraceability MatricesRisk AssessmentsData Integrity PrinciplesUser Requirements SpecificationsExecution TestingDiscrepancy Documentation
Soft Skills
Strong Written CommunicationStrong Verbal Communication
Industry Keywords
GMP RegulationsEU GMP Annex 121 CFR Part 11ISPE/GAMP PrinciplesPharmaceutical IndustryBiologicsGood Documentation Practices
Tech Stack
Tools & technologiesSDLC
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 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, roles and permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, data migration, security, and system 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 required validation, procedural, training, data, and operational-readiness activities are complete
- Review qualification documents and evidence for assigned systems or equipment
- Confirm qualification boundaries, components, prerequisites, test strategy, acceptance criteria, and required documentation
- Perform field walkdowns and document reviews
- Generate IQ/OQ protocols, incorporate comments, and support approval routing
- Execute approved IQ/OQ protocols in accordance with company procedures and Good Documentation Practices
- Document discrepancies, exceptions, and deviations and provide technical information for resolution
- Coordinate authorized retesting after corrective actions
- Assemble executed protocols and supporting evidence into complete review packages
- Generate and maintain Requirements Traceability Matrices
- Generate Qualification Summary Reports describing scope, results, deviations, open items, and qualification status
- 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
- On-site work in Aguadilla required when system access, integration testing, instrument connectivity, or execution activities cannot be adequately performed remotely
Benefits
Comp & perks- Equal opportunity employer
- Supportive, purpose-driven team environment
- Opportunity to shape the future of healthcare and technology
- Authorized remote work for document development and testing when permitted