Smartedge Solutions
Project Manager / IT Coordinator (Manufacturing Execution System (MES)
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Job Description:
The Site MES IT Coordinator serves as the primary site-level IT and MES liaison responsible for coordinating Manufacturing Execution System (MES) implementation, deployment, and ongoing operational support across manufacturing facilities. This role acts as the critical interface between site operations, Quality, MSAT, Validation, IT/OT teams, Global MES organizations, vendors, system integrators, and offshore development teams.
The successful candidate will possess strong expertise in MES platforms, manufacturing operations, and digital manufacturing technologies, ensuring seamless execution of MES programs from project initiation through go-live, hypercare, and steady-state support. The role will also drive automation and digital transformation initiatives that improve operational efficiency, data visibility, compliance, and plant connectivity.
Key Responsibilities:
MES Project Coordination & Site Governance
- Serve as the primary site-level IT coordinator and governance contact for MES implementation and support activities.
- Act as the central point of communication between site stakeholders, Global MES teams, vendors, system integrators, and offshore delivery teams.
- Coordinate all phases of the MES lifecycle, including:
- Requirements gathering
- Solution design
- Configuration and build
- Testing and validation support
- Training and user readiness
- Go-live and hypercare
- Support transition and steady-state operations
- Track and manage site-level actions, risks, issues, dependencies, decisions, and readiness activities.
- Facilitate technical and functional workshops between business users and MES delivery teams.
- Drive alignment between local manufacturing processes and enterprise MES standards/templates.
Business Process & Requirements Management
- Support business process reengineering initiatives to improve manufacturing execution and operational efficiency.
- Capture and document business requirements, process gaps, user needs, and local operational constraints.
- Translate site requirements into clear and actionable MES functional and technical specifications.
- Ensure business requirements are effectively communicated to development, configuration, and support teams.
Site Readiness & Deployment Support
- Coordinate site readiness activities including:
- Infrastructure readiness
- User access management
- Shop-floor devices
- Barcode scanners
- Label printers
- Operator terminals
- System interfaces
- Network connectivity
- Support testing activities by coordinating user participation, issue resolution, and closure of testing actions.
- Assist with training preparation, execution, and user adoption initiatives.
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Automation & Digital Manufacturing Leadership
- Lead automation and data integration projects across manufacturing sites from concept through commissioning and operational adoption.
- Coordinate technical delivery across:
- MES platforms (Rockwell MES, PharmaSuite, Siemens Opcenter, MasterControl, PAS-X, etc.) SCADA systems (Ignition, Wonderware, AVEVA, etc.)
- DCS platforms (Emerson DeltaV and similar systems)
- Data collection and historian technologies (OPC, AVEVA PI, Kepware, Litmus, etc.)
- Design and implement secure, scalable, and reliable shop-floor data collection architectures.
- Support Connected Plant and Industry 4.0 initiatives to improve plant maturity, operational visibility, and data-driven decision-making.
Compliance, Validation & Documentation
- Coordinate MES-related documentation readiness including:
- SOPs
- Work Instructions
- User Guides
- Training Materials
- Support Documentation
- Partner with Quality and Validation teams to support CSV activities and compliance requirements.
- Ensure MES solutions align with applicable regulatory and industry standards, including:
- GMP
- GAMP 5
- Annex 11 & Annex 22
- 21 CFR Part 11
- Data Integrity requirements
- Cybersecurity best practices
- Maintain documentation for decisions, issue resolutions, knowledge transfer activities, and support handovers.
Operational Support & Continuous Improvement
- Manage site-level MES governance, including:
- Demand management
- Change requests
- Incident and problem management
- Prioritization and escalation
- Coordinate L2/L3 MES support activities following implementation.
- Ensure MES systems do not negatively impact manufacturing operations.
- Identify recurring issues, training gaps, process inefficiencies, and improvement opportunities.
- Coordinate impact assessments, testing, documentation updates, training, and deployment activities for MES enhancements and changes.
Vendor & Stakeholder Management
- Build and maintain strong relationships with:
- Operations
- Manufacturing Science & Technology (MSAT)
- Quality Assurance
- Validation
- Site IT/OT Teams
- Global MES Teams
- Infrastructure Teams
- Vendors and System Integrators
- Manage third-party vendors and delivery partners to ensure compliance with technical, quality, cost, and schedule expectations.
- Champion change management initiatives and drive successful adoption of digital manufacturing solutions.
Experience:
- 8+ years of experience supporting MES implementations or manufacturing IT projects within regulated manufacturing environments.
- 5+ years of experience coordinating cross-functional teams during system deployments, upgrades, and operational support.
- 5+ years of demonstrated experience supporting manufacturing operations and shop-floor systems.
- 5+ years of experience working with global teams, vendors, system integrators, and offshore delivery organizations.
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Required Skills & Competencies:
Technical Skills
- 5+ years of strong understanding of Manufacturing Execution Systems (MES) and manufacturing operations.
- 5+ years of hands-on or functional knowledge of MES platforms such as:
- Rockwell MES (preferred)
- Werum PAS-X
- Siemens Opcenter
- PharmaSuite
- MasterControl
- 5+ years of understanding of MES integrations with:
- ERP systems
- LIMS
- Automation systems
- Barcode and labeling systems
- Reporting and analytics platforms
- Shop-floor devices
- Knowledge of SCADA, DCS, OPC, historian, and industrial connectivity technologies.
- Understanding of infrastructure, user access management, and manufacturing system support processes.
Functional Skills
- Requirements gathering and business process analysis.
- Business process reengineering and process harmonization.
- Project coordination and stakeholder management.
- Risk, issue, and change management.
- Training coordination and user adoption support.
Soft Skills
- Excellent communication, facilitation, and interpersonal skills.
- Strong stakeholder management and relationship-building capabilities.
- Ability to influence and align cross-functional teams.
- Strong analytical and problem-solving mindset.
- Ability to operate effectively in fast-paced manufacturing environments.
- Self-motivated with strong organizational and follow-up skills.
- Experience in pharmaceutical, biotechnology, life sciences, or regulated manufacturing industries.
- Familiarity with Computer System Validation (CSV) practices.
- Knowledge of GMP, GAMP 5, Annex 11, Annex 22, and 21 CFR Part 11 requirements.
- Exposure to Industry 4.0, Connected Plant, Digital Manufacturing, and Smart Factory initiatives.
- Experience supporting multi-site MES deployments and global manufacturing programs.
- Willingness and ability to travel extensively (>50%) to manufacturing sites globally for project delivery, system deployment, training, commissioning, and operational support activities.
Education:
- Bachelor’s degree in engineering, Computer Science, Information Technology, Life Sciences, Automation Engineering, or a related discipline.
- Equivalent industry experience may be considered.
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