Computer Validation Specialist - CSV for Regulated Systems

The Computer Validation Specialist will ensure computerized systems are in full compliance with regulatory requirements, company policies, and procedures. This role contributes to the development, execution, and review of validation deliverables for computer systems, hardware, and software to ensure systems are implemented according to regulatory requirements and maintained in a continuous state of quality and control.

ESSENTIAL DUTIES & RESPONSIBILITIES

Prepare, review, and approve computer validation documents for CSV projects, including: Regulatory Assessments for GxP and Part 11 relevance Validation Plans Technical Documentation (User Requirements, Functional Requirements, Design Specifications) Requirements Traceability Matrices IQ/OQ/PQ Protocols, test scripts, and reports Validation Summary Reports Review existing validation documentation for laboratory and manufacturing systems; perform retrospective validation as needed. Conduct system integration and validation testing for new/enhanced web applications. Test data integrations with Trackwise, Empower, SAP, and other systems. Perform preand post-review of validation test scripts, including defect management. Collaborate effectively with IT, Engineering, Quality, R&D, and other technical teams. Provide management updates on projects and communicate risk-based issues when necessary. Offer guidance during design, deployment, maintenance, and retirement of IT systems (in-house, contractor-developed, or off-the-shelf). Review and approve software validation documentation to ensure compliance with CSV procedures and quality system regulations. Ensure systems remain in a validated state throughout their lifecycle. Maintain inspection readiness for systems in the CSV portfolio to minimize regulatory risks. Perform periodic reviews of systems to monitor validation status. Execute other duties as assigned. EDUCATION & EXPERIENCE Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field preferred. Minimum of 4 years of System Development Life Cycle (SDLC) experience, including system integration and validation testing. Experience in software quality assurance and manual testing. Background in the Life Sciences industry. Knowledge of FDA regulatory requirements, including 21 CFR Part 11. Strong understanding of IT network infrastructure and qualification requirements. Excellent communication (oral and written) and organizational skills. Ability to work independently and collaboratively in a team environment. Familiarity with test automation tools. Experience validating laboratory systems, PLCs, and/or SAP is a plus. #J-18808-Ljbffr Compunnel Inc.