Manufacturing Execution Systems (MES) Project Manager

We are seeking an experienced Manufacturing Execution Systems (MES) Project Manager to lead end-to-end implementation and deployment projects across regulated life sciences manufacturing environments, including pharmaceutical, biotechnology, and medical device operations.

The successful candidate will be responsible for managing the full project lifecycle, from initial scoping and planning through solution design, build, testing, computer system validation, deployment, cutover, go-live, hypercare, and transition to ongoing operations. This role requires strong project leadership, a solid understanding of MES-enabled manufacturing processes, and experience delivering technology solutions in GMP-regulated environments.

Experience with Rockwell Automation PharmaSuite MES is highly preferred.

Roles and Responsibilities

• Lead end-to-end MES implementation and deployment projects across manufacturing operations.
• Develop and manage project plans, schedules, budgets, resource allocations, milestones, and delivery timelines.
• Coordinate project activities across business stakeholders, manufacturing operations, IT, automation, quality, engineering, and external implementation teams.
• Oversee project execution through requirements gathering, solution design, configuration, development, integration, testing, validation, cutover, and go-live.
• Ensure project deliverables align with GMP requirements, GAMP 5 guidance, and applicable computer system validation principles.
• Manage risks, issues, dependencies, change requests, and stakeholder expectations throughout the project lifecycle.
• Support the implementation and optimization of electronic batch records and MES-enabled manufacturing processes.
• Coordinate MES integrations with ERP, quality management systems, laboratory systems, industrial automation, historians, and other manufacturing data platforms.
• Lead deployment readiness, cutover planning, go-live execution, hypercare, issue resolution, and transition to business-as-usual operations.
• Monitor project progress, communicate status to stakeholders, and drive timely resolution of project risks and delivery challenges.
• Ensure appropriate project documentation, validation deliverables, and operational handover activities are completed.

Required Qualifications

• Bachelor's degree in Engineering, Manufacturing, Information Technology, Operations, or a related discipline. Equivalent combinations of education and relevant experience will also be considered.
• Proven experience delivering MES implementation projects end-to-end within GMP-regulated pharmaceutical, biotechnology, medical device, or life sciences manufacturing environments.
• Demonstrated experience managing projects from initial scoping and planning through design, build, testing, validation, deployment, cutover, go-live, and post-launch support.
• Strong understanding of manufacturing operations, MES functionality, and electronic batch record processes.
• Working knowledge of GAMP 5, computer system validation (CSV), and applicable GMP requirements.
• Demonstrated ability to manage project budgets, schedules, resources, risks, dependencies, and stakeholder expectations.
• Experience leading large, cross-functional project teams within complex, matrixed organizations.
• Knowledge of MES integrations with ERP, quality management, laboratory, automation, historian, and manufacturing data systems.
• Strong communication, stakeholder management, problem-solving, and project governance skills.

Preferred Qualifications

• Direct project delivery experience with Rockwell Automation PharmaSuite MES.
• Experience implementing MES solutions in pharmaceutical, biotechnology, or other highly regulated manufacturing environments.
• Familiarity with electronic batch records, manufacturing execution workflows, and production process digitization.
• Experience coordinating system integration, validation, deployment readiness, and post-go-live stabilization activities.