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Validation Engineer

JSat Automation

Glendale, California

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JOB DETAILS
SKILLS
Allen-Bradley, Analysis Skills, Automation, Automation Systems, Biotech and Pharmaceutical, Capital Project, Code of Federal Regulations, Computer Systems, Continuous Improvement, Control Systems, Current Good Manufacturing Practice (cGMP), Customer Relations, Database Technology, DeltaV, FDA (Food and Drug Administration), FDA Requirements, Foxboro, Gene Therapy, Identify Issues, Installation Guide, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Systems, Operational Support, Operations Processes, Process Control Engineering, Process Validation, Programmable Logic Controller (PLC), Quality Assurance Methodology, Regulatory Compliance, Requirements Management, Retirement Plan, Strategic Planning, Supervisory Control and Data Acquisition (SCADA), System Integration (SI), System Validation, Systems Hardware, Validation Documentation, Validation Plan, Wireless Protocols/Standards
LOCATION
Glendale, California
POSTED
Today
JSat Automation is hiring a full time Validation Engineer with Pharma Industry experience.
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<\/span><\/span>The Validation Engineer will be responsible for the following.<\/span><\/span><\/span><\/span><\/div>
  • Develop, approve, and execute process validation studies and protocols for cell and gene therapy manufacturing.<\/span><\/span><\/span>
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  • Design and develop manufacturing control systems in support of process operations.
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  • Interact with client personnel to identify and analyze continuous improvement through automation upgrades.
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  • Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices.
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  • Design, program, test and validate process control automation systems.
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  • Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements
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  • Manage, document, and implement these upgrades through changes control procedures.
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  • Execute capital projects including but not limited to:
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  • Control system software development
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  • Control system hardware design
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  • Network design
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  • MES system implementation
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  • Recipe management
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  • User requirement specification development
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  • Process equipment installations.
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  • SOP development and training on Automation Systems.
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  • Troubleshoot, analyze, and resolve field control system issues.
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  • Develop, review, and / or execute automation qualification and validation protocols.
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  • 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.<\/span><\/span>
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    Requirements<\/h3>
    • Chemical engineers preferred, with a minimum of three (3) years relevant experience.<\/span><\/span><\/span><\/span><\/span>
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    • Experience in Control Systems (Emerson<\/span><\/span> <\/span><\/span><\/span>DeltaV, Allen Bradley, Foxboro, Siemens, Honeywell). Experience with SCADA, MES, and database systems, or computer system validation are considered a plus.<\/span><\/span><\/span><\/span> <\/span><\/span><\/span>
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      <\/span><\/li><\/ul><\/div>

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      Benefits<\/h3>
      Health, PTO, Retirement Plan <\/div><\/span>

About the Company

J

JSat Automation