MissionJoin 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 ObjectivesElicit, document, and prioritise user requirements for MES & PI modulesConfigure and test MES recipes/workflows to reflect GMP-compliant processesSupport validation deliverables: URS, DQ, IQ/OQ scripts, PQ evidenceCoordinate with production, QA, IT, and validation teams to ensure seamless go-liveProvide on-the-floor hyper-care and knowledge transfer post-deploymentMust-Have Skills & Experience4–6 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 visualisationSolid grasp of the validation lifecycle: URS → DQ → IQ/OQ → PQStrong stakeholder management—comfortable presenting to operators, engineers, and QALanguages: 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 phasesNice-to-HaveISA-95 / S88 modelling experienceDeltaV, BioNet, or other DCS integration know-howPrevious tech-transfer or scale-up projects in biologicsEqual OpportunityAmaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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