Digital Quality & Lab Instrument Senior Specialist

leHACK

Hybrid
5+ years sdlc experience for lab instruments
Gmp computerized system validation knowledge
Fda 21 cfr part 11 and eu annex 11 compliance
The role leads the technical implementation and lifecycle management of analytical instruments within a global digital validation system

Job Summary

  • The role leads the technical implementation and lifecycle management of analytical instruments within a global digital validation system.
  • Candidates must ensure compliant, efficient digital laboratory workflows by executing full SDLC deliverables in GMP environments.
  • The position requires deep collaboration with vendors, quality teams, and IT partners to define requirements and maintain data integrity standards.

Matching Summary

The role leads the technical implementation and lifecycle management of analytical instruments within a global digital validation system.

Skills & Requirements

Must-have

  • 5+ years SDLC experience for lab instruments
  • GMP computerized system validation knowledge
  • FDA 21 CFR Part 11 and EU Annex 11 compliance
  • LabX standalone and client server application expertise
  • Digital Validation Systems like Kneat eVal or TOSCA
  • Instrument integration with LES systems

Nice-to-have

  • FAIR data principles and JSON schema knowledge
  • AWS Associate certification or cloud experience
  • Experience with Allotrope Ontologies
  • Scitara DLX middleware familiarity
  • Strong project management skills
  • Customer-focused mindset in matrixed environments

Key Requirements

  • Degree in life science, IT, or engineering
  • Minimum 5 years hands-on SDLC experience
  • VISA Sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter