Validation Engineer 2

Illumina

United States of America
Base: $74,900 - $112,300; bonus/equity: variable c...
On-site
Validation life cycle management system
Manufacturing process validation
Computerized system validation
Illumina is seeking a Validation Engineer 2 to join their on-site team in the United States, focusing on the validation of manufacturing processes and systems. The position requires collaboration within a dynamic environment to support new product introductions and ensure compliance with FDA regulations

Job Summary

  • The validation engineer 2 works as an integral part of the validation team supporting new product introduction, sustaining manufacturing, computerized system introduction / sustaining.
  • Develops and articulates robust strategies for validation of processes/systems and generate validation plans.
  • Ensures validation program meets requirements of FDA (21 CFR Part 11) and applicable international standards (e.g. ISO-13485).

Matching Summary

Match Score: 85

Illumina is seeking a Validation Engineer 2 to join their on-site team in the United States, focusing on the validation of manufacturing processes and systems. The position requires collaboration within a dynamic environment to support new product introductions and ensure compliance with FDA regulations.

Salary

Base: $74,900 - $112,300; Bonus/Equity: Variable cash programs (bonus or commission) and may receive equity; Benefits: Wide range of benefits including genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

Skills & Requirements

Must-have

  • Validation Life Cycle Management System
  • Manufacturing process validation
  • Computerized system validation
  • Risk management documents (FMEA)
  • FDA (21 CFR Part 11) compliance

Nice-to-have

  • Medical device/IVD industry experience
  • Quality Systems development
  • Continuous improvement methods
  • Cross-disciplinary collaboration
  • Adaptable to fast-paced environment

Key Requirements

  • Bachelor's Degree STEM field
  • 2-5 years System/process validation
  • Process engineering experience

Work Rights

Not specified

Tailored Resume

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