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