MES Consultant

Ubique Systems; Udine; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Ubique Systems in Udine, Italy seeks a Site MES IT Coordinator to lead MES project governance at the site level and to coordinate between site users, Global MES teams, IT, ERP, and offshore partners. You will drive MES lifecycle activities from requirements to go-live, ensuring alignment with GMP and data integrity standards.

The role requires strong MES knowledge, manufacturing process understanding, and the ability to travel (>50%) to client sites for activation, hypercare, and handover to

Competenze

• Bachelor degree or equivalent 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.

Mansioni

• 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 escal*ate* 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.

Conoscenze

Stakeholder management

Coordination

MES knowledge

Process understanding

Formazione

Bachelor degree or equivalent in Engineering, Computer Science, Life Sciences, Information Technology, or related field

Strumenti

Rockwell MES

Werum PAS-X

Siemens Opcenter

Descrizione del lavoro

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

• 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 escal*ate* 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

• 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

• 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.

Key Proficiencies

• 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.

Practical problem-solving approach with focus on keeping MES activities moving, users supported, and site operations protected from MES-related bottlenecks