Validation Engineer 2

Illumina Hub International Ltd

United States of America
Base: $74,900 - $112,300; bonus/equity: variable c...
On-site
Validation life cycle management system
Fda (21 cfr part 11) compliance
Iso-13485 standards
Illumina is seeking a Validation Engineer 2 to join their team, focusing on supporting new product introductions and ensuring compliance with validation processes within a dynamic work environment. The ideal candidate will have a background in system/process validation or process engineering, preferably within the medical device or in-vitro diagnostics industry

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.
  • Collaborate in a dynamic team-oriented environment and lead the effort for defining, implementing and maintaining validation for manufacturing processes and systems.
  • 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 team, focusing on supporting new product introductions and ensuring compliance with validation processes within a dynamic work environment. The ideal candidate will have a background in system/process validation or process engineering, preferably within the medical device or in-vitro diagnostics industry.

Salary

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

Skills & Requirements

Must-have

  • Validation Life Cycle Management System
  • FDA (21 CFR Part 11) compliance
  • ISO-13485 standards
  • Risk management documentation (FMEA)

Nice-to-have

  • Medical device/IVD industry experience
  • Quality Systems development
  • Process controls and continuous improvement
  • Fast-paced, dynamic work environment

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter