MES Project Leader for GMP Manufacturing

Veriipro; Canonsburg (Washington County); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Veriipro is seeking an experienced Manufacturing Execution Systems (MES) Project Manager to lead end-to-end MES implementations across regulated life sciences manufacturing environments.

You will manage scoping, planning, design, build, testing, validation, deployment, cutover, go-live, and post-launch support, ensuring GMP and CSV compliance and seamless cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, IT, Operations, or related field.
• Experience delivering MES implementation projects end-to-end within GMP-regulated life sciences environments.
• Experience managing projects from scoping through go-live and post-launch support.
• Strong understanding of MES functionality and electronic batch records.
• Knowledge of GAMP 5, CSV, and GMP requirements.
• Ability to manage budgets, schedules, resources, risks, dependencies, and stakeholders.
• Experience leading large cross-functional teams in complex matrixed organizations.
• Knowledge of MES integrations with ERP, quality, lab, automation, historians, and data systems.
• Strong communication and governance skills.

Responsabilités

• Lead end-to-end MES implementation and deployment across manufacturing operations.
• Develop 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.

Connaissances

Project leadership

GMP knowledge

GAMP 5

CSV knowledge

Cross-functional leadership

Stakeholder management

Budget management

Risk management

External teams coordination

Formation

Bachelor's degree or equivalent

Outils

Rockwell PharmaSuite MES

ERP software

Description du poste

Veriipro is seeking an experienced Manufacturing Execution Systems (MES) Project Manager to lead end-to-end MES implementations across regulated life sciences manufacturing environments.

You will manage scoping, planning, design, build, testing, validation, deployment, cutover, go-live, and post-launch support, ensuring GMP and CSV compliance and seamless cross-functional collaboration.