Validation Engineer jobs in Lancaster, CA

• Develop, approve, and execute process validation studies and protocols for cell and gene therapy manufacturing.
  
• Design and develop manufacturing control systems in support of process operations.
  
• Interact with client personnel to identify and analyze continuous improvement through automation upgrades.
  
• Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices.
  
• Design, program, test and validate process control automation systems.
  
• Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements
  
• Manage, document, and implement these upgrades through changes control procedures.
  
• Execute capital projects including but not limited to:
  
• Control system software development
  
• Control system hardware design
  
• Network design
  
• MES system implementation
  
• Recipe management
  
• User requirement specification development
  
• Process equipment installations.
  
• SOP development and training on Automation Systems.
  
• Troubleshoot, analyze, and resolve field control system issues.
  
• Develop, review, and / or execute automation qualification and validation protocols.
  
• Design, develop, and implement technical solutions by establishing integration strategies, configuring and programming PLCs, DCSs as well as design, build, install and integrate automation control system hardware, panels and field devices.
  

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