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Lead Validation Engineer

Katalyst HealthCares & Life Sciences
Indianapolis, IN
Full-time

Responsibilities :

  • For Automation Engineers who are assigned to validation projects and operate in the field, the engineer may participate in validation activities.
  • Responsible for design and implementation of key automation aspects of an equipment project, often including PLC, vision, HMI programming.
  • Design of electrical panel(s).
  • Design and PLC programming (configuration of PLC program) on standard equipment / products.
  • Vision programming (custom) and configuration primarily for Insight, Spectrum and Prism products.
  • Lead and perform complex quality checks which require an intricate understanding of the machine control systems and operations.
  • Owns and manages the Bill of Materials.
  • Responsible for installing, maintaining, and troubleshooting automated utility, processing, filing, inspection, and packaging equipment.
  • Generate user requirement specifications for control systems.
  • Able to make minor modifications to code and HMI graphics for smaller changes.
  • Must be able to read logic and perform programming as well as update control system documentation.
  • Contribute technical content to validation protocols on automation systems and perform execution of protocols.

Requirements :

  • Bachelor's Degree (Engineering or Scientific). Preferred area of study in Electrical Engineering Technology, Computer Engineering, or similar study.
  • Experience working with and programming Emerson Syncade and Delta V software platforms.
  • Exposure to FDA regulated environments including validation experience.
  • Understand CFR Part , GAMP , and other regulatory guidance associated with computer / automation-based systems.
  • Previous project management experience.
  • Recipe configuration
  • Develop and perform integration testing.
  • Develop and perform functional testing.
  • Troubleshooting experience on customer shop floor.
  • Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls).
  • Capacity to make independent sound decisions and independently manage priorities.
  • Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate with others.
  • Experience with and tolerance for high levels of challenge and change.
  • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the organization (C-Level required for higher level Automation Engineer).
  • 30+ days ago
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