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Senior Computer System Validation Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Indianapolis
Posted on: March 20, 2023

Job Description:


  • Provide CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.
  • Help drive collaboration, exceeding expectations, and challenging the status quo.
  • Develop CSV/CQV planning documents to manage CQV projects, generating and executing CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs), investigating and resolving protocols exceptions or discrepancies, developing technical reports and CSV summary reports, and starting up equipment in a safe and effective manner.
  • Perform risk assessments and impact assessments.
  • Accountable for developing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS, and summary reports.


    • Bachelor's degree in Electrical or Computer Engineering or equivalent; Higher Education Preferred
    • CSV experience in the Life Sciences industry
    • Understanding of Good Manufacturing Practices (GMPs)
    • Strong technical writing skills
    • Proficient with Microsoft Office - Word, Excel, PowerPoint, Project
    • Experience with qualifying SCADA, Delta V, Client and Client systems
    • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
    • Six Sigma Certification preferred
    • Knowledge of industry guidance a plus:
    • ISPE Baseline Guide 5 Commissioning and Qualification
    • ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
    • ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    • ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
    • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011

Keywords: Katalyst Healthcares & Life Sciences, Indianapolis , Senior Computer System Validation Engineer, IT / Software / Systems , Indianapolis, Indiana

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