Job DescriptionThe 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.
BenefitsHealth, PTO, Retirement Plan
