Validation Engineer

Katalyst HealthCares & Life Sciences · North Haven, Connecticut, United States

Location
North Haven
Job Type
Full-time
Posted
June 09, 2026

Job Description


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.
  • Lead NCMR and CAPA investigations to maintain quality system compliance.
  • Support adaptation of machine/equipment design to productio...
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