Digitalization Consultant – OSI PI – MES
Solliciteren
Plaats
Nivelles1400
Waals-Brabant
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-02-05Online to:
2026-04-06EUR 15.00 HOUR
Digitalization Consultant – OSI PI – MES
- Next-Link
- Waals-Brabant
- 22 uren geleden
Context<\/span><\/span><\/b>
<\/span> 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.<\/span>
<\/span> The MES program aims to convert paper batch records into electronic batch
records across multiple manufacturing process steps (upstream, downstream,
buffer preparation, etc.).<\/span>
<\/span> <\/span>
<\/span> <\/span>Mission Objectives<\/span><\/b>
<\/span> - The consultant will work on specific MES process packages, supporting:<\/span>
<\/span> User Requirements definition<\/span>
<\/span> Validation activities<\/span>
<\/span> Performance Qualification of MES solutions<\/span>
<\/span> <\/span>
<\/span> <\/span>Main Responsibilities<\/span><\/b>
<\/span> - Collect and write User Requirements (URS) for MES on specific process steps<\/span>
<\/span> - Understand and translate complex bio -manufacturing processes into functional
requirements<\/span>
<\/span> - Test electronic batch records directly within the MES environment<\/span>
<\/span> - Perform Performance Qualification (PQ) of MES solutions<\/span>
<\/span> - Interact with IT and validation teams throughout the lifecycle<\/span>
<\/span> - Collaborate with other MES team members during ramp‑up phase<\/span>
<\/span> - Gradually manage assigned packages autonomously<\/span>
<\/span> - Interface occasionally with OSIsoft PI for data integration needs<\/span>
<\/span> <\/span>
<\/div><\/span>
Requirements<\/h3> Must Have<\/span><\/span><\/b>
<\/span> - Experience in regulated / GxP environments<\/span>
<\/span> - Knowledge of validation lifecycle (URS, PQ, basic IQ/OQ understanding)<\/span>
<\/span> - Experience with MES systems<\/span>
<\/span> - Strong communication and stakeholder management skills<\/span>
<\/span> - Ability to work independently after onboarding<\/span>
<\/span> - English mandatory<\/span>
<\/span> - French required (at least understanding level)<\/span>
<\/span> - Willingness to work mostly on‑site<\/span>
<\/span> <\/span>
<\/span> <\/span>Nice to Have<\/span><\/b>
<\/span> - Experience in biomanufacturing or pharmaceutical production<\/span>
<\/span> - Knowledge of OSIsoft PI (nice to have, not mandatory)<\/span>
<\/span> - Techno‑functional / Business Analyst profile<\/span>
<\/span> - Experience working close to production teams<\/span>
<\/span> <\/span>
<\/div><\/span>
<\/span> 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.<\/span>
<\/span> The MES program aims to convert paper batch records into electronic batch
records across multiple manufacturing process steps (upstream, downstream,
buffer preparation, etc.).<\/span>
<\/span> <\/span>
<\/span> <\/span>Mission Objectives<\/span><\/b>
<\/span> - The consultant will work on specific MES process packages, supporting:<\/span>
<\/span> User Requirements definition<\/span>
<\/span> Validation activities<\/span>
<\/span> Performance Qualification of MES solutions<\/span>
<\/span> <\/span>
<\/span> <\/span>Main Responsibilities<\/span><\/b>
<\/span> - Collect and write User Requirements (URS) for MES on specific process steps<\/span>
<\/span> - Understand and translate complex bio -manufacturing processes into functional
requirements<\/span>
<\/span> - Test electronic batch records directly within the MES environment<\/span>
<\/span> - Perform Performance Qualification (PQ) of MES solutions<\/span>
<\/span> - Interact with IT and validation teams throughout the lifecycle<\/span>
<\/span> - Collaborate with other MES team members during ramp‑up phase<\/span>
<\/span> - Gradually manage assigned packages autonomously<\/span>
<\/span> - Interface occasionally with OSIsoft PI for data integration needs<\/span>
<\/span> <\/span>
<\/div><\/span>
Requirements<\/h3> Must Have<\/span><\/span><\/b>
<\/span> - Experience in regulated / GxP environments<\/span>
<\/span> - Knowledge of validation lifecycle (URS, PQ, basic IQ/OQ understanding)<\/span>
<\/span> - Experience with MES systems<\/span>
<\/span> - Strong communication and stakeholder management skills<\/span>
<\/span> - Ability to work independently after onboarding<\/span>
<\/span> - English mandatory<\/span>
<\/span> - French required (at least understanding level)<\/span>
<\/span> - Willingness to work mostly on‑site<\/span>
<\/span> <\/span>
<\/span> <\/span>Nice to Have<\/span><\/b>
<\/span> - Experience in biomanufacturing or pharmaceutical production<\/span>
<\/span> - Knowledge of OSIsoft PI (nice to have, not mandatory)<\/span>
<\/span> - Techno‑functional / Business Analyst profile<\/span>
<\/span> - Experience working close to production teams<\/span>
<\/span> <\/span>
<\/div><\/span>
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