Pharma Suite (Rockwell MES) Expertise Engineer

Job Summary

Horizon Controls Group is seeking an
experienced Pharma Suite (Rockwell MES) Expertise Engineer to support the
design, implementation, integration, and lifecycle management of Manufacturing
Execution Systems (MES) within a highly automated pharmaceutical manufacturing
environment.

The successful candidate will act as a subject
matter expert for Rockwell Pharma Suite MES solutions, supporting digital
manufacturing initiatives, electronic batch record (EBR) implementation, system
integration, and operational excellence programs. This role requires a strong
combination of MES technical expertise, pharmaceutical manufacturing knowledge,
and system integration capability within GMP -regulated environments.

The engineer will work closely with
Manufacturing, Automation, IT/OT, CQV, Quality, Process Engineering, and global
digital teams to ensure MES solutions are robust, scalable, compliant, and
aligned with Lilly manufacturing standards.

Key
Responsibilities

• Serve
  as the technical SME for Rockwell Pharma Suite MES applications across
  pharmaceutical manufacturing operations.
  
• Lead
  MES design, configuration, deployment, and optimisation activities
  supporting manufacturing execution and digital transformation initiatives.
  
• Develop
  and maintain Electronic Batch Records (EBRs), workflows, recipes, master
  data, and MES process models.
  
• Collaborate
  with manufacturing and process engineering teams to translate operational
  requirements into MES functional solutions.
  
• Support
  MES integration with automation and enterprise systems including PLCs,
  SCADA, historians, SAP, LIMS, and data platforms.
  
• Participate
  in MES architecture reviews, system design discussions, and digital
  manufacturing strategy initiatives.
  
• Support
  commissioning, qualification, validation, and deployment activities
  including FAT, SAT, IQ/OQ, and operational readiness.
  
• Troubleshoot
  MES system issues, investigate production events, and support root cause
  analysis within manufacturing environments.
  
• Ensure
  MES systems comply with GMP, GAMP5, ISA -95, data integrity, and
  cybersecurity standards.
  
• Develop
  and maintain technical documentation including URS, FDS, configuration
  specifications, test scripts, SOPs, and change controls.
  
• Support
  continuous improvement initiatives focused on manufacturing efficiency,
  right -first -time performance, and electronic execution.
  
• Provide
  technical mentorship and guidance to junior engineers, system users, and
  project teams.
  
• Coordinate
  with vendors, integrators, and global Lilly teams during project execution
  and system support activities.
  

Requirements

Required
Experience & Qualifications

• Degree
  in Automation, Computer Science, Software Engineering, Chemical
  Engineering, Pharmaceutical Engineering, or related discipline.
  
• Strong
  experience implementing and supporting MES platforms within pharmaceutical
  or regulated manufacturing environments.
  
• Proven
  hands -on expertise with Rockwell Pharma Suite MES is essential.
  
• Experience
  developing and supporting Electronic Batch Records (EBRs) and MES
  workflows.
  
• Strong
  understanding of pharmaceutical manufacturing processes and GMP
  operations.
  
• Experience
  integrating MES systems with automation platforms, PLCs, SCADA, SAP, LIMS,
  historians, and enterprise systems.
  
• Familiarity
  with ISA -95, ISA -88, GAMP5, 21 CFR Part 11, and data integrity
  requirements.
  
• Experience
  supporting validation lifecycle activities including CSV, IQ/OQ, and audit
  readiness.
  
• Strong
  troubleshooting, analytical, and problem -solving skills within complex
  manufacturing environments.
  
• Ability
  to work effectively across multidisciplinary technical and operational
  teams.
  

Preferred
Experience

• Experience
  within Oral Solid Dosage (OSD), biologics, API, or aseptic pharmaceutical
  manufacturing environments.
  
• Exposure
  to digital manufacturing, Industry 4.0, or smart factory initiatives.
  
• Experience
  with Rockwell FactoryTalk, PLC systems, or industrial automation
  integration.
  
• Familiarity
  with SQL databases, reporting tools, or data analytics platforms.
  
• Experience
  supporting large -scale pharmaceutical capital projects or greenfield
  facilities.
  

Key
Competencies

• Deep
  MES and Pharma Suite technical expertise
  
• Strong
  pharmaceutical manufacturing process understanding
  
• System
  integration and digital manufacturing capability
  
• Strong
  stakeholder communication and collaboration skills
  
• Attention
  to detail and compliance focus
  
• Troubleshooting
  and continuous improvement mindset