MES Project Manager (Manufacturing Systems / IT-OT Delivery)

MES Project Manager (Manufacturing Systems / IT-OT Delivery)

CornerStone Staffing – Technical Talent Solutions (TTS)

Location: Multi-site (Travel 30–50%)

Why This Role / Why CornerStone TTS

CornerStone TTS specializes in placing high-impact technology leaders into enterprise manufacturing environments where compliance, operational excellence, and digital transformation intersect. Our clients are investing in MES modernization to reduce paper-based processes, improve quality release velocity, and strengthen data integrity. They need a project leader who can deliver outcomes across both IT and operations.

This role is ideal for an experienced MES Project Manager who thrives in regulated manufacturing environments, understands IT/OT realities, and can drive cross-functional alignment across production, QA, engineering, automation, and supply chain.

Role Summary

The MES Project Manager leads the implementation of a global Manufacturing Execution System rollout across assigned manufacturing sites. You will own site-level delivery while coordinating with a global program team, ensuring adherence to global MES standards while adapting to local operational requirements and regulatory expectations.

This role requires strong cross-functional leadership and the ability to manage complex dependencies involving manufacturing processes, validation, integration, training, and change adoption.

Key Responsibilities

Project Leadership and Delivery

• Lead end-to-end MES implementation at assigned site(s): initiation, planning, execution, validation, go-live, and hyper care
• Build and maintain project plans, RAID logs, milestone tracking, and executive-ready status reporting
• Manage scope, schedule, and budget, escalating issues early and driving resolution through governance
• Coordinate with global program leadership to ensure alignment with the global template, standards, and rollout methodology
• Manage vendor and implementation partner execution and ensure deliverables meet functional and quality expectations

Stakeholder Alignment and Requirements

• Act as the primary site-level liaison across operations, QA, engineering, automation, IT, and the MES program team
• Facilitate workshops, requirements gathering, and fit-gap analysis to align business needs to global MES capabilities
• Drive alignment with site leadership on resourcing needs, process impacts, timelines, and adoption strategy
• Translate operational constraints into executable implementation plans and realistic cutover strategies

Technical and Functional Oversight

• Ensure MES design aligns with global standards while meeting local regulatory and operational requirements (GxP, GMP, 21 CFR Part 11, EU Annex 11, data integrity expectations)
• Coordinate and manage integration dependencies across the manufacturing ecosystem including ERP (SAP strongly preferred), LIMS, OEE platforms such as RedZone, and automation systems (PLC/SCADA)
• Oversee configuration management, data migration planning, functional testing, and system readiness activities
• Lead coordination between site teams, IT, OT, and vendors to ensure stable performance and production usability

Quality, Compliance, and Validation

• Ensure validation activities meet regulatory and internal quality standards, including planning and execution of CSV deliverables
• Coordinate test strategy, traceability, documentation readiness, and defect resolution through go-live
• Support QA and manufacturing teams in electronic batch record adoption and review-by-exception workflows
• Maintain audit readiness of MES records, workflows, and documentation

Organizational Change and Training

• Lead site-level change adoption activities: communications planning, engagement, end-user readiness, and adoption measurement
• Ensure role-based training execution for operators, QA, engineering, and IT support teams
• Support creation and adoption of site-specific SOPs aligned to MES-enabled processes
• Partner with site leadership to reduce resistance, build confidence, and ensure sustainable usage

Post-Go-Live Support and Continuous Improvement

• Lead hyper care execution, issue triage, and stabilization following deployment
• Capture lessons learned and feedback to improve global templates and future site rollouts
• Drive continuous improvement in MES utilization, data quality, compliance adherence, and operational performance

Required Qualifications

Education and Experience

• Bachelor’s degree in Engineering, IT, Computer Science, or related field
• 7 years of project management experience with at least 3 years delivering MES or manufacturing IT systems
• Demonstrated success delivering complex IT/OT programs in regulated environments (pharma, consumer health, FMCG, food)
• Experience with MES platforms such as Werum PAS-X, Siemens Opcenter, Rockwell PharmaSuite, AspenTech, or comparable systems
• Strong familiarity with manufacturing execution processes including batch execution, packaging, and serialization

Technical and Regulatory Knowledge

• Working knowledge of regulatory and quality expectations: GxP, GMP, 21 CFR Part 11, EU Annex 11, data integrity
• Familiarity with system validation (CSV), documentation readiness, and audit support
• Understanding of integration patterns and dependencies across SAP/Oracle ERP, LIMS, automation systems (PLC/SCADA), and digital manufacturing platforms

Core Skills

• Strong project management discipline (PMP preferred)
• Excellent stakeholder management and communication skills across shop-floor to executive audiences
• Strong analytical problem solving and decision-making capabilities
• Ability to manage multi-site and multicultural teams while maintaining governance, consistency, and execution velocity

Travel Requirement

• Willingness to travel up to 30–50% based on rollout schedule

Success Measures

• On-time, on-budget delivery aligned to defined scope and validation standards
• High adoption and sustained usage across operators, QA, production, and support teams
• Reduced paper records, fewer execution errors, and improved batch release cycle times
• Compliance with regulatory requirements and internal audit expectations
• Strong satisfaction from site leadership and global program leadership