Senior MES Engineer

Responsibilities Own MES system design, configuration, and lifecycle management for GMP manufacturing operations, from initial recipe authoring through go-live and long-term support Design and build electronic batch records (EBRs), recipes, and workflows within the MES platform Lead or support MES implementations, upgrades, and enhancements, including requirements gathering, functional design, configuration, and deployment Partner with Automation Engineering to integrate MES with DCS/SCADA, equipment, and historian systems Support CSV/CQV activities for MES changes, including authoring and executing IQ/OQ/PQ protocols Troubleshoot production issues, perform root cause analysis, and implement corrective actions with minimal manufacturing downtime Ensure MES configurations comply with GMP, data integrity (ALCOA+), and 21 CFR Part 11 requirements Collaborate with Quality and Manufacturing to translate business process requirements into MES configuration Maintain system documentation, including functional specs, configuration records, and change control documentation Mentor junior engineers and serve as a technical escalation point for MES-related issues Job Qualifications Bachelor\'s degree in Engineering, Computer Science, or related technical field (or equivalent experience) 5+ years of hands-on MES engineering experience in a GMP pharmaceutical, biotech, or CDMO manufacturing environment Full lifecycle ownership experience — has taken an MES platform through design, build, validation, and production support, not just configuration or support alone Hands-on experience with at least one major pharma MES platform: PharmaSuite (preferred), Werum PAS-X/OpCenter, or Rockwell Syncade Strong understanding of batch manufacturing processes, electronic batch records, and recipe management Experience working within a validated (CSV/CQV) environment and familiarity with GAMP 5 methodology Working knowledge of data integrity principles and 21 CFR Part 11 Ability to interface effectively with Automation, Quality, IT, and Manufacturing stakeholders #J-18808-Ljbffr