Jobid=fdcf89b2b52e (0.1)
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
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