Job Title - MES Consultant

Location: Monza & Ferentino, Italy.

Key Responsibilities

- Act as the main site-level IT coordinator and governance contact for MES project and support activities.
- Build strong working relationships with Operations, Quality, MSAT, Validation, site IT, Global MES, Infrastructure, ERP, vendors, and implementation partners to drive alignment.
- Coordinate MES lifecycle activities including requirements, design, build, testing, training, go-live, hypercare, support handover, and steady-state operations.
- Track site-level MES actions, risks, issues, dependencies, decisions, and readiness items with clear ownership and follow-up.
- Coordinate technical and functional discussions between site users, Global MES teams, and offshore development/configuration teams.
- Support business process reengineering and help align site processes with the core MES template, standard ways of working, and practical shopfloor needs.
- Drive clarity in MES requirements by capturing site feedback, process gaps, user needs, and local constraints in a structured way.
- Support site readiness activities including infrastructure, user access, shopfloor devices, printers, scanners, terminals, interfaces, and connectivity.
- Coordinate required testing and compliance-related activities by helping site teams participate, provide inputs, and close actions as needed.
- Log, track, and escalate MES issues to the right support teams with clear business impact, priority, and required details.
- Support creation and update of MES-related documents such as SOPs, work instructions, user guides, support guides, and training materials.
- Ensure smooth communication between site teams, Global MES teams, support teams, and offshore delivery teams.
- Lead automation and data projects across DSD manufacturing sites,



from concept and design through commissioning, validation, and user adoption.
- Own and coordinate technical delivery across SCADA systems (Ignition, Wonderware, etc.), DCS systems (Emerson DeltaV), MES platforms (PharmaSuite, OpCenter, MasterControl, etc.), and data capture/historization systems (OPC, Aveva PI, Kepware, Litmus, etc.).
- Design and deploy data collection architectures that enable secure, reliable data flow from shop-floor automation systems to enterprise analytics platforms.
- Champion change management and adoption, ensuring stakeholders and site users fully embrace new digital solutions.
- Define and enforce standards for system design, configuration, and data management consistent with GMP, GAMP 5, Annex 11 and 22, 21 CFR Part 11, and cybersecurity best practices.
- Collaborate cross-functionally with process engineering, IT/OT, validation, operations, Quality, MSAT, and Global MES teams to deliver integrated, business-ready solutions.
- Manage vendors and system integrators, ensuring adherence to technical specifications, schedule, cost, delivery quality, and issue resolution expectations.
- Drive the Connected Plant and digital enablement strategy, increasing plant maturity and improving data visibility across the Drug Substance network.
- Travel frequently (>50%) to provide on-site leadership, support project execution, and facilitate system handover and training.

Continuous Improvement





- Manage site-level MES governance by coordinating demand, changes, open tickets, priorities, escalations, and improvement items.
- Coordinate L2/L3 site support after MES implementation and support users with MES issues, questions, and support follow-up.
- Work with Operations, Quality, MSAT, Validation, Global MES, and support teams to ensure MES does not become a bottleneck for site operations.
- Identify recurring issues, support gaps, training needs, process pain points, and improvement opportunities to strengthen MES operations at the site level.
- Support site-level MES change requests, impact assessment, testing coordination, documentation updates, training coordination, and adoption follow-up.

Qualifications

- Bachelor degree or equivalent experience in Engineering, Computer Science, Life Sciences, Information Technology, or related field.
- Experience supporting MES implementation or site IT project coordination in manufacturing environments.
- Deep understanding of manufacturing processes, shopfloor operations, and MES platforms.
- Strong functional and technical understanding of MES applications, interfaces, user access, infrastructure, shopfloor devices, and support processes.
- Experience in business process reengineering, process alignment, requirements clarification, and translating site needs into clear MES requirements.
- Understanding of regulated manufacturing environments and CSV expectations is preferred.
- Experience coordinating with business users, Operations, Quality, MSAT, Validation, IT, Infrastructure, vendors, implementation partners, offshore development teams, and support teams.
- Ability to support users at site level during implementation, go-live, hypercare, steady-state operations, and issue resolution.

📌 MES Consultant (Monza)
🏢 Multinational
📍 Monza