MES MBR Designer

Role – MES MBR Designer – Small Molecule (Werum PAS-X)

About the client/Project – The resources will support the migration of the Torre Annunziata small molecule production site from the existing PAS-X v2 environment to PAS-X v3.4 / Client Global MES Template. Scope includes assessment and redesign/rebuild of existing MBRs, PAS-X configuration, gap analysis, verification/testing, defect resolution, change control and collaboration with Process, QA and Automation teams.

• Service Line – Life Science Manufacturing

Experience/Skill Details (in years):

• Overall experience – Preference for experienced PAS-X MBR Designers
• Relevant experience – Hands‑on Werum PAS‑X MBR design/build experience; experience with PAS‑X migrations or major version upgrades, ideally PAS‑X v2 to v3.4
• Mandatory skill required – Hands‑on Werum PAS‑X MBR design/build experience; experience with PAS‑X migrations or major version upgrades (ideally v2 to v3.4); experience with GMP small molecule / solid dose or API manufacturing; MBR configuration including calculations, branching, e-signatures, exception handling and material/equipment integration; experience with testing, validation, change control and documentation in a regulated environment
• Required level of additional language – Italian (mandatory, fluent – project language); English (working proficiency)
• If Hybrid/Onsite share the travel location – Travel to Torre Annunziata, Italy, as required – up to 30% of the project duration