Lead Techno-Functional MES Consultant – Biomanufacturing Digitalization

Our client, a global leader in the pharmaceutical industry, is seeking a Techno-Functional Consultant to support the digitalization of manufacturing processes. The role focuses on converting paper-based batch records into electronic formats to modernize operations within a specialized production environment.

• Collect and document User Requirements (URS) for specific manufacturing process steps.
• Translate complex biomanufacturing processes into actionable functional requirements.
• Execute testing of electronic batch records directly within the manufacturing execution environment.
• Perform Performance Qualification (PQ) for digital manufacturing solutions.
• Coordinate with IT and validation teams throughout the project lifecycle.
• Interface with data integration systems to support production data requirements.

• Experience with MES (Manufacturing Execution Systems).
• Knowledge of the validation lifecycle including URS, PQ, and basic IQ/OQ.
• Proven experience working within regulated GxP environments.
• Strong communication and stakeholder management skills.
• Ability to work independently following an initial onboarding phase.
• You are fluent in English with at least passive knowledge of French.

Nice to Haves

• Experience in biomanufacturing or pharmaceutical production environments.
• Knowledge of OSIsoft PI.
• Techno-functional or Business Analyst profile.
• Experience collaborating closely with production teams.

• Start date: ASAP
• Duration: project length
• Work regime: Full-time
• Location: Braine-l'Alleud
• Working model: Hybrid (mostly onsite, up to 2 days remote). Role is VDI only (no hardware provided).
• Contract: open to both permanent employees and freelancers.