Digitalization Consultant – OSI PI – MES

Context

To support the digitalisation of manufacturing processes, we are looking for a Techno‑Functional Consultant to work on MES (Manufacturing Execution System) projects within the Bio Manufacturing Unit. The MES program aims to convert paper batch records into electronic batch records across multiple manufacturing process steps (upstream, downstream, buffer preparation, etc.).

Mission Objectives

• The consultant will work on specific MES process packages, supporting:
  • User Requirements definition
  • Validation activities
  • Performance Qualification of MES solutions

Main Responsibilities

• Collect and write User Requirements (URS) for MES on specific process steps
• Understand and translate complex bio‑manufacturing processes into functional requirements
• Test electronic batch records directly within the MES environment
• Perform Performance Qualification (PQ) of MES solutions
• Interact with IT and validation teams throughout the lifecycle
• Collaborate with other MES team members during ramp‑up phase
• Gradually manage assigned packages autonomously
• Interface occasionally with OSIsoft PI for data integration needs

Requirements

Must Have

• Experience in regulated / GxP environments
• Knowledge of validation lifecycle (URS, PQ, basic IQ/OQ understanding)
• Experience with MES systems
• Strong communication and stakeholder management skills
• Ability to work independently after onboarding
• English mandatory
• French required (at least understanding level)
• Willingness to work mostly on‑site

Nice to Have

• Experience in biomanufacturing or pharmaceutical production
• Knowledge of OSIsoft PI (nice to have, not mandatory)
• Techno‑functional / Business Analyst profile
• Experience working close to production teams