Biopharma MES Techno-Functional Lead

Techno Functional Consultant MES – Freelance | Belgium near BrusselsContract:Initial twelve months with strong possibility of extensionMissionWe are supporting a Belgian Biopharmaceutical company with twoMES techno/functional consultanthires. They are looking for two consultants to support the digitalisation of biomanufacturing processes by helping convert paper batch records into fully electronic batch records across upstream, downstream and buffer preparation steps.What you will do

• Collect and write User Requirements URS for MES
• Translate biomanufacturing process steps into clear functional requirements
• Test electronic batch records within the MES environment
• Carry out Performance Qualification PQ activities
• Work closely with IT and validation teams
• Gradually take full ownership of assigned MES work packages
• Occasionally collaborate with OSIsoft PI teams for data integration needs

Must have

• Experience in regulated or GxP environments
• Understanding of validation lifecycle including URS PQ and basic IQ and OQ
• Hands on MES experience
• Strong communication and stakeholder management
• Able to work independently after onboarding
• English required and French at least at understanding level
• Comfortable being mostly on site

Nice to have

• Background in biomanufacturing or pharmaceutical production
• Knowledge of OSIsoft PI
• Techno functional or Business Analyst type profile
• Experience working close to production teams

Work setup

• Location is Braine l'Alleud in Belgium
• Mostly on site with up to two days remote per week
• Candidates must already be based in Belgium

Please only apply if you have hands-on experience in pharmaceutical or biomanufacturing environments, working on MES within regulated manufacturing settings.