Operations Technology MES Systems Analyst
About The Position
Nephron Pharmaceuticals is seeking a results-oriented MES Systems Analyst 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 collaborates with Manufacturing, Quality Assurance, Engineering, Validation, Supply Chain, and Technology teams to ensure MES solutions support compliant, efficient, and reliable pharmaceutical manufacturing operations. The MES Systems Analyst serves as a technical and business resource for electronic batch records (EBR), manufacturing workflows, recipe management, system integrations, and data integrity initiatives, ensuring compliance with GMP, FDA, and global regulatory requirements. The ideal candidate will have a proven track record of teamwork, strong analytical and problem-solving skills, and demonstrated success in problem-solving and solution implementation. High initiative, attention to detail, and experience in a service-driven, dynamic environment are essential. This role offers significant on-the-job learning, mentorship, and growth opportunities within the Technology Support team, which focuses on maintaining user uptime through remote monitoring, maintenance, troubleshooting, and exceptional customer service.
Requirements
- 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.
- 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.
Nice To Haves
- Certification in Rockwell Automation technologies or related manufacturing preferred.
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.
- Coordinate 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
