Computer System Validation Engineer

Hello,

Computer System Validation Engineer

Qualifications

EDUCATION & EXPERIENCE: Minimum of 6 years of System Development Life Cycle experience, including system integration and validation testingSoftware quality assuranceExperience in manual testingExperience in the Life Sciences industryKnowledge of FDA regulatory requirements, including 21 CFR Parts 11 Strong understanding of IT network infrastructure and required qualifications Excellent communication (oral and written) and organizational skills

Responsibilities:Coordinate and lead Computer System Validation (CSV) activities to ensure computerized and automation systems are in full compliance with regulatory requirements, company policies, and proceduresServe as the subject matter expert to provide compliance oversight to cross-functional team's Computer System Validation (CSV) projectsPrepare, review, and approve various computer validation documents for CSV projects including the following:Regulatory Assessment for determination of GxP and Part 11 relevanceValidation Plan,Technical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications)Requirements Traceability Matrix Risk Assessment IQ/OQ/PQ Protocols, test scripts and Reports,Validation Summary ReportReview existing validation documentation for the computerized systems used in laboratory and manufacturing floor and retrospectively validate systems as neededSystem integration and validation testing for new/enhanced web applicationsPerform pre and post-review and approval of validation test scripts including test defectsInterface effectively with management personnel in IT, Engineering, Quality, R, and other technical disciplinesProvides management with updates on projects, and when necessary, communicates risk-based issue Provides value-added guidance during the design, deployment, maintenance, and retirement of IT computer systemThis guidance applies to all systems developed in house, developed by contractors, and off the shelf (COTS) softwareMay perform supplemental research to provide options for compliant solutions to barriers encountered during validation Reviews and approves software validation documentation to ensure documentation is compliant with CSV procedures and all applicable quality system regulations or Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation Ensures that the system's validation state is maintained throughout the system life cycleEnsure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibilityPerforms a periodic review of systems to monitor the validation status of the system