MES Change Management Lead

Sector:  Medical Devices

Engagement:  Contract

Level:  Senior / Lead

Location:  Galway

Duration: 12 months

The Opportunity

Our client, a leading global medical device manufacturer at their Galway facility, is embarking on a significant digital manufacturing programme and is looking for an experienced MES Change Management Lead to help drive it forward.

This is a pivotal contract role for someone who thrives at the meeting point of technology, quality and people. You’ll own the change management process for the site’s Manufacturing Execution System (MES) ensuring every change is delivered compliantly, safely and with the buy in of the teams who use the system every day. You’ll work with senior leadership, site wide managers, engineers and product builders to embed new ways of working and keep the operation moving.

The Role

Reporting to the Site lead you will lead the end-to-end change management for the MES platform across the site covering both the technical change control that keeps the system validated and compliant, and the organisational change that gets people confidently using it.

Key Responsibilities

• Lead and govern the change control process for the MES platform, from change request through impact assessment, approval, implementation and closure.
• Own change management for MES driven manufacturing including electronic batch records, workflows and master data ensuring changes are risk assessed and controlled.
• Partner with senior leadership to plan, prioritise and sequence changes in line with the digital manufacturing roadmap and production schedules.
• Coordinate cross functional stakeholders across Production, Quality, IT/Automation, Validation and Engineering to deliver changes with minimal disruption to the line.
• Ensure all changes meet GxP requirements, data integrity expectations and applicable regulations.
• Oversee the computer system validation (CSV/CSA) activities associated with MES changes, working closely with validation teams and documentation owners.
• Manage change documentation updating SOPs, work instructions and training materials so they stay accurate and audit ready.
• Drive the people side of change prepare, engage and train managers, engineers and product builders so new MES workflows are adopted quickly and confidently.
• Support deviation, CAPA and audit activities relating to MES changes, and act as a point of contact during regulatory and customer audits.
• Contribute to MES upgrades, new module rollouts and paperless / Industry 4.0 initiatives as the site matures its digital manufacturing capability.

About You

Essential

• Proven experience leading change management within a regulated MES / digital manufacturing environment ideally in medical devices, pharma or a comparable GxP setting.
• Strong working knowledge of an MES platform.
• Solid understanding of change control and quality management systems and of validated computer systems.
• Excellent stakeholder management able to influence and align senior leaders, technical teams and product builders alike.
• Confident communicator who can translate technical change into clear, practical guidance for the people affected by it.

Desirable

• Degree in Engineering, Manufacturing, Computer Science, Life Sciences or a related discipline.
• Formal project or change management credentials (e.g. PMP, PRINCE2, Prosci / ADKAR, Lean Six Sigma).
• Experience supporting MES implementations, upgrades or migrations.
• Familiarity with ISO 13485 and EU MDR in a medical device context.
• Prior experience in a matrixed, multi-site or global manufacturing organisation.

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