JOB DESCRIPTION:
Job Title: Digitalization Consultant – OSI PI - MES
Duration: ASAP-6 months with possible extension
Location: Braine-L'alleud, WAL, Belgium
Mode: Hybrid
Language: English, French
Work Regime: Full time
The team is responsible for several digital transformation projects in a regulated biomanufacturing environment.
The MES program aims to convert paper batch records into electronic batch records across multiple manufacturing process steps (upstream, downstream, buffer preparation, etc.).
Main Responsibilities:
Collect and write User Requirements (URS) for MES on specific process steps
Understand and translate complex biomanufacturing 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
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
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