MES Change Specialist

Key Responsibilities

• Lead requirements gathering and initial assessments for MES modifications based on manufacturing and operational needs.
  
• Translate operational requirements into MES recipe and workflow specifications.
  
• Develop, author, and execute Computerized Systems Validation (CSV) protocols, including Configuration Verification (CV) and Functional Verification (FV) testing.
  
• Create and execute test scripts and test plans for MES changes, new recipes, and workflow modifications.
  
• Investigate and assess exceptions and deviations identified during validation testing, ensuring appropriate resolution and documentation.
  
• Own the end-to-end MES change management process for assigned manufacturing processes, from initiation and impact assessment through testing, implementation, and closure.
  
• Manage MES-related deviations, including complex or multi-site issues associated with system defects, and ensure corrective actions effectively address root causes.
  
• Monitor project schedules, identify risks or delays, and escalate concerns to leadership in a timely manner.
  
• Troubleshoot mechanical and automation-related production issues and identify opportunities to improve system performance, reduce costs, and increase operational efficiency through data analysis.
  
• Support site initiatives involving capital projects, technology transfers, Drug Substance (DS) and Drug Product (DP) changes, shutdowns, and new product launches.
  
• Collaborate with Manufacturing, P&C, IT/OT, Master Data, Quality, and other stakeholders to ensure effective implementation of MES changes.
  
• Provide MES-related audit support, including system demonstrations, presentations, documentation, and responses to auditor questions.
  
• Support the resolution and closure of MES-related regulatory findings, as required.
  

Required Qualifications

• Bachelor’s degree in a relevant field with 3–5 years of experience in MES, Electronic Batch Records (EBR), or computerized systems in regulated manufacturing, or a relevant master’s degree.
  
• Hands-on experience with the construction, testing, and validation of computerized systems.
  
• Experience managing electronic change control processes using systems such as Veeva Quality or TrackWise.
  
• Knowledge of Computerized Systems Validation (CSV), Computer Software Assurance (CSA), GAMP principles, and quality systems.
  
• Experience developing and executing test scripts, validation protocols, test plans, and technical documentation.
  
• Understanding of electronic data systems, data integrity, and regulatory compliance requirements.
  
• Familiarity with manufacturing automation systems, including SAP, MES, Programmable Logic Controllers (PLCs), and Human-Machine Interfaces (HMIs).
  
• Experience working in a regulated pharmaceutical or biotechnology manufacturing environment.
  
• Demonstrated ability to manage change requests, coordinate cross-functional action items, and drive changes through implementation and closure.
  
• Strong troubleshooting, analytical, documentation, communication, and project coordination skills.
  

Preferred Qualifications

• Experience in sterile pharmaceutical manufacturing, including solution preparation, equipment preparation, formulation, vial filling, lyophilization, prefilled syringes (PFS), inspection, or packaging.
  
• Experience troubleshooting Rockwell Automation systems, including remote or on-site support.
  
• Prior involvement in MES or Electronic Batch Record (EBR) deployment projects.
  
• Experience supporting manufacturing technology transfers, capital projects, and new product launches.
  
• Experience investigating complex MES defects, deviations, and corrective and preventive actions (CAPA).