MES Lead

Responsibilities

• Lead strategy, roadmap, and lifecycle management for the site's MES platform, ensuring alignment with business, quality, and regulatory objectives
• Own configuration, deployment, and support of MES electronic batch records (eBR), recipe management, and workflow modules
• Lead MES integration efforts with automation systems (PLC/SCADA/DCS), ERP, LIMS, and other plant IT/OT systems
• Serve as MES subject matter expert (SME) during internal audits and external regulatory inspections (FDA, ISO), including front room/back room support
• Lead validation and qualification (IQ/OQ/PQ) activities for MES implementations, upgrades, and configuration changes in partnership with Validation and Quality teams
• Author and approve MES functional/technical specifications, configuration documentation, and change control records
• Lead root cause investigations for MES-related deviations, system downtime, and data integrity issues
• Drive MES rollout and adoption across new product lines, manufacturing sites, or process areas, including end-user training and change management
• Partner with Manufacturing, Quality, Automation, IT, and Process Engineering to translate business requirements into MES configuration and workflow design
• Mentor and provide technical guidance to junior MES analysts/engineers on system configuration, troubleshooting, and documentation practices
• Manage vendor relationships for MES software providers and system integrators, ensuring quality, timeline, and budget adherence on projects
• Drive continuous improvement initiatives to enhance data integrity, electronic batch record accuracy, and shop-floor efficiency through MES
• Ensure MES design, configuration, and documentation comply with FDA regulations, cGMP, 21 CFR Part 11, GAMP 5, and internal quality/data integrity standards
• Lead risk assessments (FMEA) for MES changes, upgrades, or new site/process rollouts
• Support long-term digital manufacturing/Industry 4.0 initiatives, identifying opportunities to expand MES capabilities across the site

Qualifications

Required:

• Bachelor's degree in Engineering, Information Technology, Computer Science, or related field
• 5+ years of experience with Manufacturing Execution Systems (e.g., Werum PAS-X, Rockwell PharmaSuite, Siemens Opcenter, or similar) in pharmaceutical, biotech, or medical device manufacturing
• Strong working knowledge of cGMP, FDA regulations, 21 CFR Part 11, and GAMP 5 as applied to computerized manufacturing systems
• Demonstrated experience leading MES implementation, configuration, or upgrade projects from requirements through go-live
• Experience supporting or leading FDA/regulatory inspections as an MES SME
• Strong understanding of electronic batch records, recipe management, and shop-floor data integrity principles
• Proficiency in leading cross-functional teams and managing vendor/system integrator relationships
• Excellent written and verbal communication skills, with ability to influence cross-functional stakeholders and present to leadership
• Proven ability to manage multiple MES projects simultaneously, including budgets, timelines, and resource coordination
• Willingness to work on the production floor, including gowning/cleanroom protocols as required