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
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Serve as the technical SME for Rockwell Pharma Suite MES applications across pharmaceutical manufacturing operations.
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Lead MES design, configuration, deployment, and optimisation activities supporting manufacturing execution and digital transformation initiatives.
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Develop and maintain Electronic Batch Records (EBRs), workflows, recipes, master data, and MES process models.
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Collaborate with manufacturing and process engineering teams to translate operational requirements into MES functional solutions.
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Support MES integration with automation and enterprise systems including PLCs, SCADA, historians, SAP, LIMS, and data platforms.
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Participate in MES architecture reviews, system design discussions, and digital manufacturing strategy initiatives.
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Support commissioning, qualification, validation, and deployment activities including FAT, SAT, IQ/OQ, and operational readiness.
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Troubleshoot MES system issues, investigate production events, and support root cause analysis within manufacturing environments.
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Ensure MES systems comply with GMP, GAMP5, ISA-95, data integrity, and cybersecurity standards.
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Develop and maintain technical documentation including URS, FDS, configuration specifications, test scripts, SOPs, and change controls.
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Support continuous improvement initiatives focused on manufacturing efficiency, right-first-time performance, and electronic execution.
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Provide technical mentorship and guidance to junior engineers, system users, and project teams.
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Coordinate with vendors, integrators, and global Lilly teams during project execution and system support activities.
Required Experience & Qualifications
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Degree in Automation, Computer Science, Software Engineering, Chemical Engineering, Pharmaceutical Engineering, or related discipline.
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Strong experience implementing and supporting MES platforms within pharmaceutical or regulated manufacturing environments.
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Proven hands-on expertise with Rockwell Pharma Suite MES is essential.
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Experience developing and supporting Electronic Batch Records (EBRs) and MES workflows.
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Strong understanding of pharmaceutical manufacturing processes and GMP operations.
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Experience integrating MES systems with automation platforms, PLCs, SCADA, SAP, LIMS, historians, and enterprise systems.
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Familiarity with ISA-95, ISA-88, GAMP5, 21 CFR Part 11, and data integrity requirements.
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Experience supporting validation lifecycle activities including CSV, IQ/OQ, and audit readiness.
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Strong troubleshooting, analytical, and problem-solving skills within complex manufacturing environments.
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Ability to work effectively across multidisciplinary technical and operational teams.
Preferred Experience
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Experience within Oral Solid Dosage (OSD), biologics, API, or aseptic pharmaceutical manufacturing environments.
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Exposure to digital manufacturing, Industry 4.0, or smart factory initiatives.
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Experience with Rockwell FactoryTalk, PLC systems, or industrial automation integration.
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Familiarity with SQL databases, reporting tools, or data analytics platforms.
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Experience supporting large-scale pharmaceutical capital projects or greenfield facilities.
Key Competencies
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Deep MES and Pharma Suite technical expertise
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Strong pharmaceutical manufacturing process understanding
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System integration and digital manufacturing capability
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Strong stakeholder communication and collaboration skills
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Attention to detail and compliance focus
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Troubleshooting and continuous improvement mindset
