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
Equal Opportunity Amaris 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.
#J-18808-Ljbffr