MES Consultant

Location: Gaggio Montano

Position Overview
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 elevate 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 (Pharma Suite, OpCenter, Master Control, 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…