MES Consultant

Job Title : MES Consultant

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Location: Monza & Ferentino, Italy .

Work Mode: Onsite (Full time).

Job Description

The Site MES IT Coordinator will support Manufacturing Execution System (MES) project implementation and post-go-live support at the manufacturing site level. This role will act as the key coordination point between site users, Global MES teams, IT, Infrastructure, ERP, offshore development/configuration teams, vendors, and implementation partners. The role requires a strong functional and technical understanding of MES platforms and manufacturing processes, with the ability to drive clarity in requirements, support business process reengineering, manage site-level MES governance, and coordinate activities across the MES lifecycle from project start and site readiness through go-live, hypercare, and steady-state support.

Key Responsibilities

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• 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 escalat 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.
  

Compliance & Documentation

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• Support site documentation readiness for MES processes, user roles, support model, SOPs, work instructions, user guides, and training materials.
  
• Coordinate required compliance and CSV inputs with Quality and Validation teams, while keeping the role focused on site MES coordination and readiness.
  
• Ensure site-level documentation and support materials are updated when MES processes, access, devices, interfaces, or support models change.
  
• Maintain clear site records for key decisions, open actions, issue follow-ups, knowledge transfer, and support handover.
  

Continuous Improvement

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• 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

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• 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.
  

Key Proficiencies

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• Excellent stakeholder management, coordination, communication, follow-up, issue tracking, and relationship-building skills.
  
• Ability to develop strong relationships with Operations, Quality, MSAT, Validation, site IT, Global MES, and offshore development teams to drive alignment.
  
• Deep knowledge of MES platforms; experience with Rockwell MES is preferred, and knowledge of Werum PAS-X, Siemens Opcenter, or other MES applications is good to have.
  
• Understanding of MES integration with ERP, LIMS, automation systems, barcode systems, label printing, reporting systems, and shopfloor devices is preferred.
  
• Ability to manage MES governance at site level, including priorities, open issues, changes, risks, decisions, and support readiness.
  
• Ability to drive clarity in requirements and work effectively with both site teams and offshore development/configuration teams. xysqume
  
• Practical problem-solving approach with focus on keeping MES activities moving, users supported, and site operations protected from MES-related bottlenecks.
  

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