MES Project Manager

Katalyst-Healthcares-; City of Albany (NY); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Katalyst-Healthcares- is seeking an experienced MES Project Manager to lead end-to-end MES implementations, upgrades, and enhancements in GMP‑regulated environments. This role demands strong MES expertise, project management, and a track record in life sciences manufacturing.

You will manage cross-functional teams, develop robust project plans, ensure CSV/data integrity, and coordinate with IT, QA, Validation, and external vendors to deliver on schedule and within budget.

Qualifications

• Experience leading MES projects in pharmaceutical/manufacturing environments.
• Knowledge of GMP/GxP, CSV, data integrity, and regulated system documentation.
• Proven ability to plan, manage risks, engage stakeholders and coordinate vendors.

Responsabilités

• Lead end-to-end MES projects including implementation, upgrade and deployment.
• Develop and manage plans, timelines, budgets, resources, deliverables, and risks.
• Coordinate cross-functional teams across Manufacturing, QA, Validation, IT, and vendors.

Connaissances

MES

Project management

GMP

CSV

Vendor coordination

Cross-functional leadership

Formation

Bachelor's degree in engineering / CS / IT / Pharmaceutical Sciences or related field

Master's degree in engineering / PM / IS or related

Outils

EBR systems

ERP integration

LIMS integration

SCADA systems

Description du poste

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.
• 5-7 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.