MES Project Manager (Manufacturing Systems / IT-OT Delivery)
hace 2 días
Dallas
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