Pharma Suite (Rockwell MES) Expertise Engineer
Key Skills
Job Description
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
Core Responsibilities
Serve as the technical subject matter expert for Rockwell Pharma Suite MES to design, implement, and optimize digital manufacturing solutions. Lead the development of Electronic Batch Records and ensure seamless integration between MES and enterprise systems like SAP and LIMS.
Requirements
Requires a degree in Engineering or Computer Science with proven hands-on expertise in Rockwell Pharma Suite and MES implementation within GMP-regulated environments. Must be proficient in pharmaceutical manufacturing processes, validation lifecycles, and industry standards such as ISA-95 and GAMP5.
About Horizon Controls Group
Industry: Industrial Automation
Company size: 51-200 employees
Horizon Controls Group: A global leader in automation consulting, enabling both clients and employees to live on the forefront of evolving technology. Horizon Controls Group is a modern, global technology company, specializing in automation consulting, engineering, and training. Founded on the belief that our people are the difference, we have grown entirely from customer references and successive projects. Our people and their established reputation are our most valued assets. This belief has created a great place to work, enabling us to attract the very best and to give our customers confidence in our superior solutions. Our business is comprised of excellence at every level. We employ a pro-active and comprehensive approach to projects -- asking the right questions, analyzing client needs, and engineering a skilled solution. We are committed to understanding the entire spectrum of your automation challenges and to developing uniquely tailored innovative solutions. Our decision to be vendor-independent enables us to offer tailored solutions and represent your needs free of any conflict of interest. We are aligned exclusively with our customers' goals and system requirements, enabling us to provide maximum value. Ultimately, the ability to harvest maximum value from new systems is dependent on the quality and training of your people. Just as we expect and ensure absolute expertise in our people, we work with you to ensure your team is trained to the specific needs of your organization and remain at the forefront of industry trends. We are a global company operating in the United States from our headquarters in Conshohocken, PA and offices in Indiana, Massachusetts, North Carolina, and California and from Cork in Ireland. This is Horizon Controls Group’s official company LinkedIn page.