Digital Quality & Lab Instrument Senior Specialist
Merck & Co., Inc.
Hybrid
5+ years sdlc experience for lab instrumentation
Gmp environment computerized system validation
Knowledge of fda 21 cfr part 11 and eu annex 11
The role involves leading the technical implementation and lifecycle management of analytical instruments across global laboratories to support high-quality science
Job Summary
The role involves leading the technical implementation and lifecycle management of analytical instruments across global laboratories to support high-quality science.
Candidates must possess a deep understanding of Data Integrity regulations including FDA 21 CFR Part 11 and EU Annex 11 to ensure compliant digital workflows.
The position requires collaborating with cross-functional teams to translate business processes into digital requirements while maintaining full SDLC documentation.
Matching Summary
The role involves leading the technical implementation and lifecycle management of analytical instruments across global laboratories to support high-quality science.
Skills & Requirements
Must-have
5+ years SDLC experience for lab instrumentation
GMP environment computerized system validation
Knowledge of FDA 21 CFR Part 11 and EU Annex 11
Experience with LabX or similar standalone applications
Digital Validation Systems like Kneat eVal or TOSCA