Principal Automation, MES Engineer

• The Principal Automation & MES Engineer is responsible for the design, implementation, optimization, and lifecycle management of Manufacturing Execution Systems (MES)
• Lead the design, configuration, deployment, and continuous improvement of MES solutions to support manufacturing operations, electronic batch execution, data integrity, and operational efficiency
• Support integration of MES platforms with enterprise and site systems including ERP, LIMS, historians, SCADA/DCS, CMMS, and data analytics platforms
• Define and maintain MES governance, standards, lifecycle management practices, and system roadmaps aligned with business objectives
• Participate in enterprise digital manufacturing initiatives
• Provide technical leadership for automation and process control systems including DeltaV, SCADA, PLC, HMI, and related manufacturing control platforms
• Ensure manufacturing systems remain compliant with GMP, FDA, GAMP5, and 21 CFR Part 11 requirements
• Lead or contribute to capital projects, system implementations, upgrades, migrations, and site expansion initiatives
• Identify opportunities to improve manufacturing efficiency, data visibility, system reliability, and process robustness

• Bachelor’s or Master’s degree in Engineering, Computer Science, Biotechnology, Automation, or related technical discipline
• 10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
• Strong experience with Manufacturing Execution Systems (MES) platforms such as PAS-X, Syncade, Pharma Suite, Opcenter, or equivalent
• Experience with process automation platforms such as DeltaV, Siemens, Allen-Bradley, Wonderware, Ignition, or related technologies
• Demonstrated experience supporting validated manufacturing systems within GMP-regulated environments
• Strong understanding of FDA regulations, GAMP5, SDLC methodologies, and 21 CFR Part 11 compliance requirements
• Proven experience leading complex technical projects and cross-functional engineering initiatives
• Experience with system integration, manufacturing data flows, and enterprise application connectivity
• Strong analytical, troubleshooting, organizational, and communication skills
• Ability to work effectively across global teams, manufacturing sites, and external partners.

Demonstrates expertise in the design, implementation, and optimization of Manufacturing Execution Systems (MES) while ensuring compliance with GMP, FDA, and GAMP5 standards. Proven ability to lead complex technical projects and enhance manufacturing efficiency through effective system integration and data management.

• Manufacturing Execution Systems (MES)
• Process Automation Platforms
• GMP Compliance
• FDA Regulations
• System Integration

• Manufacturing Execution Systems (MES)
• Process Automation
• System Integration
• Data Analytics
• Technical Project Leadership
• GMP Compliance
• FDA Regulations
• GAMP5
• 21 CFR Part 11
• SDLC Methodologies

• Analytical Skills
• Troubleshooting
• Organizational Skills
• Communication Skills

• Pharmaceutical Manufacturing
• Biotechnology
• Medical Device Manufacturing
• Regulated Environments

• DeltaV
• SCADA
• PLC
• HMI
• PAS-X
• Syncade
• Pharma Suite
• Opcenter
• Siemens
• Allen-Bradley