Digital Quality & Lab Instrument Senior Specialist

Merck & Co., Inc.

Hybrid
Sdlc documentation for laboratory instrumentation
Gmp environment compliance knowledge
Digital validation systems experience
The role involves leading the technical implementation and sustainment of global laboratory instruments while ensuring full compliance with digital validation standards

Job Summary

  • The role involves leading the technical implementation and sustainment of global laboratory instruments while ensuring full compliance with digital validation standards.
  • Candidates must possess deep technical knowledge of standalone and client-server applications like LabX and execute SDLC deliverables in GMP environments.
  • This position requires strong collaboration with cross-functional teams to define requirements and drive efficiency across global quality and manufacturing labs.

Matching Summary

The role involves leading the technical implementation and sustainment of global laboratory instruments while ensuring full compliance with digital validation standards.

Skills & Requirements

Must-have

  • SDLC documentation for laboratory instrumentation
  • GMP environment compliance knowledge
  • Digital Validation Systems experience
  • Computerized systems qualification principles
  • FDA 21 CFR Part 11 and EU Annex 11
  • Instrument integration with LES systems

Nice-to-have

  • FAIR data principles and JSON schemas
  • Allotrope Ontologies or Simple Models
  • AWS Associate certification or cloud experience
  • Scitara DLX instrument middleware experience
  • Strong project management skills
  • Customer-focused mindset in matrixed environment

Key Requirements

  • Degree in life science, IT, or engineering
  • Minimum 5 years hands-on experience
  • Experience with COTS systems in GMP
  • Knowledge of Data Integrity regulations
  • VISA Sponsorship available

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter