Validation Engineer

• 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.

Requirements

Benefits