Job description
Mission
Join the digitalisation program for a leading bio-manufacturing unit, converting paper batch records into electronic workflows via MES and OSIsoft PI. You will own specific MES/PI process packages (upstream, downstream, buffer prep) and drive them from user requirements through to qualification.
Key Objectives
• Elicit, document, and prioritise user requirements for MES & PI modules
• Configure and test MES recipes/workflows to reflect GMP-compliant processes
• Support validation deliverables: URS, DQ, IQ/OQ scripts, PQ evidence
• Coordinate with production, QA, IT, and validation teams to ensure seamless go-live
• Provide on-the-floor hyper-care and knowledge transfer post-deployment
Must-Have Skills & Experience
• 4–6 years in a GxP-regulated manufacturing environment (pharma, biotech, or med-tech)
• Hands-on exposure to MES platforms (Werum PAS-X, Syncade, or similar)
• Proven use of OSIsoft PI for process data collection and visualisation
• Solid grasp of the validation lifecycle: URS → DQ → IQ/OQ → PQ
• Strong stakeholder management—comfortable presenting to operators, engineers, and QA
• Languages: fluent English (written & spoken) + working-level French (production floor is French-speaking)
• Willingness to be on-site 4–5 days/week during design, testing, and rollout phases
Nice-to-Have
• ISA-95 / S88 modelling experience
• DeltaV, BioNet, or other DCS integration know-how
• Previous tech-transfer or scale-up projects in biologics
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.