Job Description
🚨 We’re Hiring: Computer Validation Specialist (CSV)
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📍 Location: Plantation, FL – Onsite
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VirtueAmerica is actively seeking an experienced Computer Validation Specialist to support computerized system validation, regulatory compliance, and validation lifecycle management within a regulated life sciences environment.
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The ideal candidate will have hands-on experience developing and executing validation documentation, performing system integration and manual testing, and ensuring computerized systems comply with applicable regulatory requirements and data integrity standards.
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KeyRequirements:
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• Minimum of 4 years of SDLC experience, including system integration and validation testing within a regulated industry.
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• Strong understanding of Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP 5 guidelines, and data integrity principles.
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• Knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, and applicable regulatory requirements for computerized systems.
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• Experience preparing, executing, reviewing, and approving validation deliverables, including User Requirements Specifications (URS), Functional Requirements, Risk Assessments, Requirements Traceability Matrices (RTMs), IQ/OQ/PQ protocols, test scripts, and Validation Summary Reports.
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• Hands-on experience with manual testing, risk-based validation testing, system integration testing, and troubleshooting validation-related issues.
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• Experience reviewing existing validation documentation and supporting retrospective
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📌 #MandatoryRequirement: Candidates must and should provide 2 Manager-level professional references along with their resume for consideration. Profiles submitted without the required references will not be considered.
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