Senior Manager MES System

Key Responsibilities

Platform Ownership & Strategy

• Own the MES platform end-to-end, including PAS-X core, integrations, infrastructure, and supporting services.

• Define and execute the MES platform strategy aligned with site and enterprise manufacturing priorities.

• Establish and maintain a multi-year MES roadmap covering sustainment, modernization, scalability, and technical debt reduction.

• Serve as the single accountable decision owner for MES platform architecture, risk, and trade-offs.

DevOps & Operational Excellence

• Own the DevOps operating model for MES, including incident, problem, change, release, and deployment management.

• Ensure high availability, performance, and reliability of MES in a 24x7 GMP manufacturing environment.

• Lead root cause analysis for critical incidents and drive systemic corrective and preventive actions.

• Oversee system upgrades, patches, enhancements, and infrastructure changes with minimal manufacturing disruption.

• Define and monitor operational SLAs, KPIs, and reliability metrics.

Compliance, Validation & Quality

• Own the MES validation strategy (IQ/OQ/PQ) in alignment with GxP, GAMP 5, and 21 CFR Part 11 requirements.

• Ensure continuous inspection readiness through strong documentation, controls, and operating discipline.

• Partner with Quality to ensure compliance is embedded in solution design, delivery, and operations.

• Accountable for audit readiness, support, responses, observations, and remediation related to MES.

Delivery & Continuous Improvement

• Govern intake, prioritization, and delivery of MES enhancements and business requests.

• Balance run and change demand to ensure predictable delivery without compromising system stability.

• Drive standardization, simplification, and reuse across MES workflows and configurations.

• Identify and sponsor opportunities for automation, analytics, and AI-enabled improvements.

People Leadership

• Lead, coach, and develop a multi-disciplinary MES DevOps and development team.

• Set clear roles, expectations, and accountability across support, development, and delivery functions.

• Build team capability and resilience through succession planning, cross-training, and skills development.

• Foster a culture of ownership, quality, continuous improvement, and collaboration.

Stakeholder & Financial Management

• Serve as a senior interface to Manufacturing, Packaging, Quality, Automation, Warehouse, and IT leadership.

• Translate business priorities into executable MES outcomes and investment decisions.

• Own and manage MES operating and project budgets, including forecasting and cost control.

• Provide concise executive-level communication on platform health, risks, and roadmap progress.

Basic Qualifications

• Bachelor’s degree in IT, Engineering, Computer Science, or a related discipline (or equivalent experience).

• 10+ years of experience supporting or leading MES or manufacturing systems in a regulated (GxP) environment.

• Demonstrated experience owning and operating mission-critical platforms in a 24x7 environment.

• Proven people management experience leading technical teams.

• Strong working knowledge of PAS-X MES platforms.

Preferred Qualifications

• Experience establishing DevOps or product-centric operating models in regulated manufacturing.

• Direct accountability for audits, inspections, and regulatory interactions related to MES.

• Experience managing both run and change budgets for large enterprise platforms.

• Knowledge of SAP–MES integration, ISA-95 / S88, and OT/automation interfaces.

• Certification in PAS-X MES systems.

• Experience with leveraging AI/ML.

• Strong executive communication and stakeholder management skills.