Manager, IT Manufacturing Execution Systems

Role Summary

The MES System Manager will drive efficiency and reliability in our manufacturing processes. This role involves developing Manufacturing Execution System (MES) support strategies, collaborating with vendors, optimizing system performance, and ensuring compliance with GxP regulations. Location: Burlington, MA—in-office Monday–Thursday, with flexibility to work remotely on Fridays.

Responsibilities

• Develop and maintain an MES support strategy that integrates manufacturing process knowledge, equipment design, and quality standards with information technology to reduce downtime.
• Collaborate closely with internal staff and external vendors to evaluate and implement MES application upgrades, hotfixes, and enhancements.
• Continuously monitor MES system performance, review logs, and diagnostic data, and respond appropriately to ensure optimal operation.
• Partner closely with Manufacturing organization to acquire a deep understanding of manufacturing processes and system configurations to provide well-informed recommendations for system optimization.
• Regularly review and update SOPs, reference materials, and other controlled content.
• Provide on-call support for EBR/APS systems as needed to maintain uninterrupted operations.
• Mentor and train new MES resources, both internal and external, to foster a skilled and knowledgeable team.
• Manage software and configurations required for external system interfaces, facilitating seamless data exchange.
• Contribute to, facilitate, review, and update system development lifecycle and validation documents as needed for GxP IT implementation and enhancement projects.
• Support multiple ongoing IT initiatives within the MES environment, aligning technology solutions with business requirements.
• Regularly evaluate business requirements and propose effective solutions, actively engaging with end users and stakeholders to plan and execute system enhancements and related changes.

Qualifications

• Preferred: Five to eight years experience with enterprise systems, ideally in MES solution deployment and knowledge of MES technologies such as Siemens OpCenter Execution Pharma (EBR) and OpCenter APS (Scheduling) would be preferable.
• Experience in Pharmaceutical, Biotechnology, or Life Sciences industry.
• Preferred: Database administration knowledge for Oracle, SQL and/or other platforms is preferable.
• Preferred: Knowledge of business intelligence platforms such as PowerBI and other data ETL and modeling tools is preferred.
• Demonstrated leadership skills and experience working in diverse, multi-disciplined work groups.
• Preferred: Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity preferred.

Education

• Required: Bachelor's degree in Computer Science, Information Technology, or Business Administration.