Validation Engineer

Job Description
JSat Automation is hiring a full time Validation Engineer with Pharma Industry experience.

The Validation Engineer will be responsible for the following.

• 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

• Chemical engineers preferred, with a minimum of three (3) years relevant experience.
• Experience in Control Systems (Emerson DeltaV, Allen Bradley, Foxboro, Siemens, Honeywell). Experience with SCADA, MES, and database systems, or computer system validation are considered a plus.

Benefits

Health, PTO, Retirement Plan