Ph3Mission /h3pJoin 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. /ph3Key Objectives /h3ulliElicit, document, and prioritise user requirements for MES PI modules /liliConfigure and test MES recipes/workflows to reflect GMP-compliant processes /liliSupport validation deliverables: URS, DQ, IQ/OQ scripts, PQ evidence /liliCoordinate with production, QA, IT, and validation teams to ensure seamless go-live /liliProvide on-the-floor hyper-care and knowledge transfer post-deployment /li /ulh3Must-Have Skills Experience /h3ulli4–6 years in a GxP-regulated manufacturing environment (pharma, biotech, or med-tech) /liliHands-on exposure to MES platforms (Werum PAS-X, Syncade, or similar) /liliProven use of OSIsoft PI for process data collection and visualisation /liliSolid grasp of the validation lifecycle: URS → DQ → IQ/OQ → PQ /liliStrong stakeholder management—comfortable presenting to operators, engineers, and QA /liliLanguages: fluent English (written spoken) + working-level French (production floor is French-speaking) /liliWillingness to be on-site 4–5 days/week during design, testing, and rollout phases /li /ulh3Nice-to-Have /h3ulliISA-95 / S88 modelling experience /liliDeltaV, BioNet, or other DCS integration know-how /liliPrevious tech-transfer or scale-up projects in biologics /li /ulh3Equal Opportunity /h3pAmaris 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. /p /p #J-18808-Ljbffr