Rockwell Pharma Suite MES Expert | EBR & GMP Champion

Horizon Controls Group; Netherlands; Remote; EUR 70,000 - 100,000; Full time

Job summary

Horizon Controls Group in Leiden, Netherlands seeks an experienced Pharma Suite (Rockwell MES) Expertise Engineer to support design, implementation, integration, and lifecycle management of MES within a highly automated pharmaceutical manufacturing environment.

You will serve as the SME for Rockwell Pharma Suite MES, supporting digital manufacturing initiatives, EBR implementation, system integration, and operational excellence programs.

Qualifications

• Degree in Automation, Computer Science, Software Engineering, Chemical Engineering, Pharmaceutical Engineering, or related discipline.
• Strong experience implementing and supporting MES platforms in regulated pharmaceutical environments.
• Proven hands-on expertise with Rockwell Pharma Suite MES.
• Experience developing and supporting Electronic Batch Records (EBRs) and MES workflows.
• Strong understanding of GMP operations and pharmaceutical manufacturing processes.
• Experience integrating MES with 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 across complex manufacturing environments.

Responsibilities

• Serve as the technical SME for Rockwell Pharma Suite MES across pharmaceutical manufacturing operations.
• Lead MES design, configuration, deployment, and optimization activities for manufacturing execution and digital transformation.
• 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 solutions.
• Support MES integration with automation and enterprise systems including PLCs, SCADA, SAP, LIMS, and data platforms.
• Participate in MES architecture reviews and digital manufacturing strategy discussions.
• Support commissioning, qualification, validation, and deployment activities including FAT, SAT, IQ/OQ, and operational readiness.
• Troubleshoot MES issues, investigate production events, and perform root cause analysis.
• Ensure MES systems comply with GMP, GAMP5, data integrity, and cybersecurity standards.
• Develop and maintain technical documentation (URS, FDS, configuration specs, test scripts, SOPs, change controls).
• Support continuous improvement initiatives focused on efficiency and right-first-time execution.

Skills

Rockwell Pharma Suite

MES implementation

EBR development

GMP knowledge

System integration

ISA-95/ISA-88

CSV/IQ-OQ

Troubleshooting

Cross-functional teamwork

Education

Degree in Automation/CS/Software Eng/Pharma Eng

Job description

Horizon Controls Group in Leiden, Netherlands seeks an experienced Pharma Suite (Rockwell MES) Expertise Engineer to support design, implementation, integration, and lifecycle management of MES within a highly automated pharmaceutical manufacturing environment.

You will serve as the SME for Rockwell Pharma Suite MES, supporting digital manufacturing initiatives, EBR implementation, system integration, and operational excellence programs.