Site MES IT Coordinator

JOB DETAILS:

Position: Site MES IT Coordinator

Location: Cincinnati, OH Onsite

Type of Employment: 12+ Months Contract

Role 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.

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.
• 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.

Required Skills & Competencies

• 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.

Preferred Qualifications:

• 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.

Travel Requirements:

• Willingness and ability to travel extensively (>50%) to manufacturing sites globally for project delivery, system deployment, training, commissioning, and operational support activities.