Description
The VIE will be responsible for the implementation of a new data management tool designed to monitor analytical method performance across the method lifecycle, in line with regulatory and quality expectations (e.g. trending, control charts, automated alerts).
The role has a strong junior project leadership dimension, with a high level of autonomy and responsibility, in close collaboration with Analytical, Quality, and IT teams across multiple sites.
Main Activities:
Analytical Data Management & Method Lifecycle
· Implement a systematic analytical data management solution to monitor analytical method performance
· Analyze and interpret data generated by various analytical techniques (chromatography, UV, titration, etc.)
· Develop performance indicators, trending tools, and automated alert systems
Digital Tools & Interfaces
· Develop or coordinate the development of interfaces integrated with existing laboratory systems, including:
o Electronic Laboratory Notebook (ELN)
o Data acquisition / chromatography software
o Stock or sample management tools
· Support cross-site harmonization, automation, and digitalization of laboratory processes
Solution Definition & Market Analysis
· Perform a market analysis of available digital solutions
· Assess tools based on functionality, compliance, scalability, and cost
· Prepare or contribute to:
o User Requirement Specifications (URS)
o Functional requirements documentation
o Budget estimation and feasibility assessment
Project Leadership & Communication
· Take operational ownership of the project and its deliverables
· Coordinate stakeholders from Analytical, IT, Quality, and Project Management teams
· Communicate project progress, risks, and results to both technical and non-technical audiences