Computer System Validation Engineer

Wilmington, DE, US • Posted 1 day ago • Updated 3 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • GAMP
  • Sarbanes-Oxley
  • ISO 9000
  • ITIL
  • Inspection
  • Auditing
  • Corrective And Preventive Action
  • Management
  • SOP
  • Regulatory Compliance
  • URS
  • Reporting
  • Veeva
  • Risk-based Testing
  • Biostatistics
  • Regulatory Affairs
  • Robotic Process Automation
  • Research and Development
  • Artificial Intelligence
  • Science
  • Pharmacy
  • Computerized System Validation
  • GxP

Summary

Roles & Responsibilities :
  • 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
  • uthoring of URS/FS, protocols, final reports, validation plan/report
  • High-level understanding of Veeva Vault suits
  • Risk-based testing aligned to CSA fundamentals
  • High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

Education & Experience :
  • Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
  • Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 69bcfdef4424cd7508ebd7187b2bf50c
  • Posted 1 day ago
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