Digital Quality & Lab Instrument Senior Specialist
Merck & Co., Inc.
Rahway, NJ, USA
Hybrid
5+ years sdlc experience for lab instruments
Gmp environment computerized system validation
Knowledge of fda 21 cfr part 11 and eu annex 11
The role leads the technical implementation and lifecycle management of analytical instruments within a digital validation system to support global quality labs
Job Summary
The role leads the technical implementation and lifecycle management of analytical instruments within a digital validation system to support global quality labs.
Candidates must possess deep technical knowledge of standalone and client-server applications like LabX while ensuring strict adherence to data integrity regulations.
This position requires collaborating across functional boundaries to define requirements, execute full SDLC deliverables, and maintain compliant documentation templates.
Matching Summary
The role leads the technical implementation and lifecycle management of analytical instruments within a digital validation system to support global quality labs.
Skills & Requirements
Must-have
5+ years SDLC experience for lab instruments
GMP environment computerized system validation
Knowledge of FDA 21 CFR Part 11 and EU Annex 11
Experience with Kneat eVal, X-Ray, or TOSCA tools
Strong background in life science or engineering degree
Nice-to-have
FAIR data principles and JSON schema knowledge
Experience with Allotrope Ontologies or Simple Models