MES Consultant

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 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.

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