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Validation Engineer

Company

Katalyst Healthcares & Life Sciences

Location

North Haven, Connecticut, United States

Type

Full-time

Job Summary:

  • Validation Engineer Manufacturing Operations responsible for overseeing complex production processes for surgical devices, leading validation activities, troubleshooting electro-mechanical systems, and ensuring manufacturing efficiency, compliance, and quality standards.


Roles & Responsibilities:


  • Oversee and optimize complex production processes for surgical devices to meet efficiency and quality standards.

  • Serve as the primary technical expert for electro-mechanical equipment issues, perform root cause analysis, and implement corrective actions to reduce downtime.

  • Lead development and execution of validation strategies including IQ/OQ/PQ for new and existing equipment.

  • Apply Lean principles to identify waste reduction and improve process stability.

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