Senior Computer System Validation Engineer

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

Job Description:

Responsibilities:

• 
  
• 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.
  
  Requirements:
  
  
  • 
    
  • 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