MES Project Manager is expected to be onsite in Greenville, North Carolina, USA.
The MES Project Manager is responsible for leading the planning, implementation, validation, and deployment of Manufacturing Execution System solutions within a regulated life sciences manufacturing environment. This role coordinates cross-functional teams, system integrators, software vendors, and business stakeholders to deliver MES projects that improve manufacturing operations, data integrity, compliance, and product quality.
The successful candidate will have experience managing complex technology and manufacturing projects in pharmaceutical, biotechnology, medical device, or other regulated industries. The role requires a strong understanding of Good Manufacturing Practices, computerized system validation, manufacturing processes, and enterprise system integration.
Lead MES projects from initiation through design, configuration, testing, validation, deployment, and operational handover.
Develop and maintain project charters, scope, schedules, budgets, resource plans, risk registers, and governance documentation.
Coordinate activities across manufacturing, quality, engineering, automation, IT, validation, supply chain, and external implementation partners.
Translate business and manufacturing requirements into clear project deliverables and implementation plans.
Manage MES workstreams involving electronic batch records, electronic work instructions, equipment integration, material tracking, genealogy, exception management, review by exception, and production reporting.
Ensure project execution complies with applicable regulatory and quality requirements, including GxP, current Good Manufacturing Practices, data-integrity principles, and computerized system validation procedures.
Partner with Quality and Validation teams to develop and execute validation strategies, including user requirements, functional and design specifications, risk assessments, traceability matrices, test protocols, and validation summary reports.
Manage system interfaces with enterprise and manufacturing platforms, such as ERP, laboratory information management systems, warehouse management systems, process historians, automation systems, and equipment-control platforms.
Facilitate workshops, design reviews, risk assessments, steering committee meetings, and project status reviews.
Monitor project performance, identify schedule or budget variances, and implement corrective actions.
Manage project risks, issues, dependencies, assumptions, decisions, and change requests.
Coordinate vendor selection, contracting, statements of work, deliverables, and performance.
Support site readiness, data migration, training, cutover planning, go-live activities, and post-implementation stabilization.
Establish effective communication and escalation processes for project stakeholders.
Ensure complete and controlled project documentation in accordance with company quality systems and record-retention requirements.
Support the development of MES standards, templates, governance models, and implementation methodologies for future deployments.
Promote adoption of new digital manufacturing processes through stakeholder engagement, training, and organizational change management.
Capture lessons learned and identify opportunities for continuous improvement.
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