MES Engineer/Specialist
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The MES Engineer sits within the Site Engineering & Maintenance Department and is responsible for the implementation, maintenance, optimisation and lifecycle management of the site Manufacturing Execution System (MES) and associated integrations.
Acting as the Business System Owner (BSO) and technical SME for MES, the role ensures that the system remains reliable, compliant and fit for manufacturing needs while supporting system enhancements, IoT device integration, site projects and digitalisation initiatives.
Main Accountabilities
Act as the Business System Owner (BSO) and SME for MES, leading system configuration, maintenance, upgrades and continuous improvement to support manufacturing requirements.
Develop and maintain MES system architecture, databases, Process Instructions and technical specifications, ensuring alignment with global design standards and site requirements.
Maintain and optimise interfaces and connectivity between MES and other site systems, including integration of relevant IoT devices and digital solutions.
Provide advanced technical support, troubleshoot complex MES issues and collaborate closely with the Digital team and system vendors to ensure timely resolution and minimise system downtime.
Lead the implementation of MES-related activities arising from site projects, change controls, deviations and CAPAs, providing technical expertise from design through commissioning and operational handover.
Support the Computerised System Validation (CSV) lifecycle, including validation activities, system changes, documentation and maintenance of the validated state.
Ensure MES remains compliant with GMP, data integrity, cybersecurity and applicable regulatory requirements, including appropriate user access, security controls, system backup and recovery processes.
Serve as the MES SME during regulatory inspections, internal audits and self-inspections, supporting documentation, investigations and remediation activities as required.
Monitor system performance, downtime and deviations, identify recurring issues and drive improvements to enhance system reliability, operational efficiency and user experience.
Develop and maintain relevant SOPs, technical documentation, system specifications and engineering records in accordance with site Quality and Engineering standards.
Provide technical training and ongoing support to operations and end users, ensuring appropriate understanding and use of MES functionalities.
Manage MES system vendors for technical support, troubleshooting, maintenance and project execution, including review of technical proposals and vendor documentation.
Participate in global MES and digital networks, sharing lessons learned and supporting global initiatives while ensuring alignment with global standards and design guidelines.
Key Decision / Advisory Responsibilities
The MES Engineer will have responsibility for determining appropriate system configurations and technical optimisation strategies, while providing expert advice on troubleshooting, system performance and technical solutions. The role will monitor and report MES downtime and deviations, contribute technical expertise throughout the validation lifecycle, and support compliance documentation, inspections and continuous improvement activities.
Key Interfaces
The role will work closely with Manufacturing, Engineering & Maintenance, Digital/IT, Automation, Quality, Validation, Global MES teams and external system vendors to ensure reliable, compliant and effective operation of the site's MES environment.
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Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 2556 comparable Manufacturing & CMC roles across 173 biopharma companies.
Salary context
663 of 2556 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
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Seniority mix
1172 of 2556 peers have a known seniority level
Therapeutic area mix
12 of 2556 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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