MES Project Manager

Job Summary

We are seeking an experienced MES Project Manager to lead end-to-end Manufacturing Execution System (MES) implementation, upgrade, and enhancement projects within pharmaceutical, biotechnology, or life sciences manufacturing environments. The ideal candidate will possess strong MES technical expertise, project management capabilities, and experience working in GMP-regulated environments.

Roles And Responsibilities

• Lead end-to-end MES implementation, upgrade, enhancement, and deployment projects across digital manufacturing programs.
• Develop and manage project plans, timelines, budgets, resource allocation, deliverables, and risk mitigation strategies.
• Coordinate cross-functional teams, including Manufacturing, Quality Assurance, Validation, Automation, IT, and external vendors.
• Provide technical leadership for MES solution design, configuration, implementation, integration, testing, and deployment.
• Manage Electronic Batch Records (EBR), electronic workflows, manufacturing processes, and shop-floor system requirements.
• Oversee MES integration with ERP, LIMS, SCADA, automation platforms, and other manufacturing systems.
• Coordinate requirements gathering, functional specifications, user acceptance testing (UAT), system testing, deployment, and hyper care support.
• Ensure compliance with GMP, GxP, data integrity, and computer system validation (CSV) requirements throughout the project lifecycle.
• Manage project risks, issues, dependencies, change requests, and escalation processes to ensure timely delivery.
• Drive stakeholder communication, project governance, status reporting, executive updates, and vendor management.
• Support digital manufacturing transformation initiatives, process optimization, and continuous improvement programs.
• Ensure project documentation, validation deliverables, and quality records are completed in accordance with regulatory and organizational standards.
  
  

Education & Experience

• Bachelor's degree in engineering, Computer Science, Information Technology, Pharmaceutical Sciences, Biotechnology, or a related field.
• A master's degree in engineering, Project Management, Information Systems, or a related discipline is preferred.
• 57 years of hands-on MES experience within pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environments.
• Proven experience leading MES implementation, upgrade, migration, or enhancement projects from initiation through deployment and post-go-live support.
• Practical knowledge of GMP/GxP compliance, data integrity principles, computer system validation (CSV), and regulated system documentation.
• Demonstrated experience in project planning, risk management, stakeholder engagement, vendor coordination, and cross-functional team leadership.