MES Systems Manager

Responsibilities

• Represent the site with central platform teams to ensure reliable MES operations, appropriate prioritization, and clear decision-making on defects/enhancements.
• Serve as the primary site advocate to secure timely incident support (including off-hours escalation as needed).
• Lead site incident, problem, and change management for MES (triage, root cause, and corrective/preventive actions).
• Own and drive CAPAs to completion with non-negotiable due dates.
• Facilitate and/or participate in rapid-improvement workshops (kaizen/accelerator events) to improve MES-supported processes and usability.
• Lead the site MES solutions team in designing and improving eBRS workflows.
• Configure, test, and deploy simple to medium-complexity changes within the site instance(s); coordinate more complex changes with central platform teams and/or third-party partners.
• Manage site MES initiatives (upgrades, integrations, new deployments, and retirements), coordinating engineering, production, quality, and IT stakeholders through requirements, testing, validation, cutover, and hypercare.
• Ensure MES compliance, validation, and data integrity in alignment with applicable regulations and internal standards.
• Maintain required documentation (e.g., risk assessments, test evidence, release approvals) and serve as a technical/functional SME during audits and regulatory inspections.
• Coach and mentor site users and technical staff on MES best practices, training, and continuous improvement.
• Most customers are operations personnel; success requires regular shop-floor engagement (seated workspace will be in an admin area).
• Own the site MES demand/roadmap: collect and translate user needs into requirements, support prioritization, and ensure alignment to global templates and site business priorities.
• Oversee MES user access and role management (including segregation of duties), ensuring appropriate controls, periodic reviews, and timely provisioning/deprovisioning in coordination with IT/security processes.
• Establish and track operational performance metrics (e.g., uptime, incident trends, release quality, cycle-time impacts) and communicate status, risks, and priorities to site leadership and platform partners.
• Manage site vendor engagements as applicable (service requests, statements of work, scheduling, and deliverable acceptance) and support budget/forecast inputs for MES-related site work.
• Lead and develop a small site MES solutions team: set priorities, assign work, ensure quality and compliance of deliverables, and support capability building and succession planning.

Qualifications

• Bachelor’s degree in engineering, computer science, information systems, or related technical field, or equivalent experience.
• 5+ years’ experience supporting and/or managing MES in a regulated manufacturing environment.
• Functional understanding of pharma manufacturing processes.
• Experience with MES platforms (e.g. eBRS, Weigh & Dispense, IPC, Serialization) including design, configuration, administration and troubleshooting.
• Familiarity with electronic batch records (eBRS) solutions. Experience with computer system validation and supporting validated systems.
• Knowledge of system interfacing technologies/concepts (e.g., ERP, LIMS, historians, or PLC/SCADA systems).
• Stakeholder management and experience working across operations, quality, engineering, and IT.
• Experience leading process improvement initiatives and coaching colleagues to adopt new ways of working.
• Experience leading a small team and/or leading through influence in a matrix environment (including prioritization, coaching, and performance management).