Operations Technology MES Systems Analyst

Job Purpose

We are looking for a results-oriented MES Systems Analyst who is responsible for the administration, configuration, support, validation, and continuous improvement of the Manufacturing Execution System (MES) environment, with a primary focus on Rockwell PharmaSuite. This role works closely with Manufacturing, Quality Assurance, Engineering, Validation, Supply Chain, and Technology teams to ensure MES solutions support compliant, efficient, and reliable pharmaceutical manufacturing operations.

Essential Duties and Responsibilities

• Administer, maintain, and support the Rockwell PharmaSuite MES platform.
• Monitor MES system performance, availability, and reliability.
• Troubleshoot and resolve MES-related incidents, deviations, and production issues.
• Manage system configurations, master data, security roles, and user access controls.
• Cook up software updates, patches, and system lifecycle activities.
• Configure and maintain electronic batch records (EBRs), workflows, recipes, and manufacturing process models.
• Design and implement MES enhancements that improve manufacturing efficiency, quality, and compliance.
• Develop and maintain equipment models, materials definitions, production workflows, and process parameters.
• Support deployment of new products, processes, and manufacturing lines within PharmaSuite.
• Support integration between PharmaSuite and enterprise systems including ERP, LIMS, SCADA, historians, and automation platforms.
• Collaborate with automation and Technology teams to troubleshoot interface and data exchange issues.
• Ensure accurate and reliable transfer of manufacturing and quality data between systems.
• Identify opportunities to improve manufacturing processes through MES functionality and automation.
• Develop metrics and reporting tools that enhance operational visibility and manufacturing performance.
• Support digital transformation initiatives and paperless manufacturing strategies.
• Participate in cross-functional projects focused on operational excellence and manufacturing modernization.
• Provide MES technical support to manufacturing, quality, and engineering personnel.
• Develop and maintain MES training materials and procedures.
• Train end users on MES functionality and best practices.
• Serve as a subject matter expert for PharmaSuite-related processes and technologies.

Knowledge & Skills

• Knowledge of FDA 21 CFR Part 11, Data Integrity, GAMP 5, and GMP regulations.
• Strong troubleshooting, analytical, and problem-solving skills.
• Excellent written and verbal communication skills.
• Experience with Rockwell PharmaSuite implementation, administration, or development.
• Experience integrating MES with ERP systems such as SAP, NetSuite, or Oracle.
• Knowledge of PLC, SCADA, and industrial automation systems.
• Experience with SQL databases, reporting tools, and data analytics.
• Familiarity with serialization, genealogy, track-and-trace, or manufacturing intelligence systems.
• Certification in Rockwell Automation technologies or related manufacturing preferred

Education/Experience

• Bachelor's degree in Engineering, Computer Science, Information Systems, Biotechnology, Pharmaceutical Sciences, or related field preferred.
• Minimum 3–5 years of experience supporting Manufacturing Execution Systems in a regulated manufacturing environment.
• Hands-on experience with Rockwell PharmaSuite or comparable MES platforms.
• Experience with pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing operations.
• Strong understanding of manufacturing processes, batch execution, and electronic batch records.
• Experience supporting validated systems and computer system validation activities.

Working Conditions / Physical Requirements

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.