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Validation Engineer

Validation Engineer

Industry: Pharma
Job Type: Full Time
Job Location: Glendale
Work Experience: 5+ years
State: California

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

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