Director, MES Implementation & Integration

Regeneron Pharmaceuticals

71d • $145,600 - $282,600

About The Position

The Director of MES (Implementation and Integration) will drive the end-to-end implementation of Manufacturing Execution Systems (MES) across our biopharmaceutical facilities. You will design and execute integration architectures connecting MES with Ignition, DeltaV, and Rockwell platforms, ensuring seamless deployment across retrofitted and future facilities while modernizing workflows to meet regulatory and operational standards. As a Director, MES Implementation & Integration, a typical day might include the following: Contribute to the strategic vision of MES and manage the implementation and integration of the MES system across all IOPS sites. Develop strong business relationships with relevant stakeholder groups to attain a solid understanding of their goals and objectives to ensure alignment with the overall MES strategy. Develop tailored frameworks for MES integration with Ignition plant hubs, DeltaV control systems, and Rockwell HMI platforms, addressing distinct technical paradigms rather than unified strategies. Establish master data architecture frameworks to enable system deployment, ensuring validation and regulatory compliance across FDA-regulated environments. Manage complex validation requirements and change control processes while transforming paper-based batch records into compliant digital workflows. Diagnose and resolve integration challenges, including connectivity issues between disparate automation platforms, while maintaining quality and timeline constraints. Redesign workflow processes to leverage integrated system capabilities, optimizing operational efficiency and regulatory readiness. Provide MES team members with guidance and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals. Lead and/or participate in projects and initiatives as assigned by management.

Requirements

• Comprehensive understanding of biopharmaceutical manufacturing processes, batch record requirements, validation standards, and change control procedures within FDA-regulated environments.
• Experience managing process digitization initiatives that maintain regulatory compliance.
• Deep expertise addressing integration challenges across different automation platforms and system architectures.
• Demonstrated ability diagnosing complex technical problems and implementing solutions under timeline pressure.

Nice To Haves

• BS degree in a life sciences, computer science or engineering discipline or related field.
• 10+ years of pharmaceutical/biotechnology industry experience for Associate Director level.
• 12+ years of pharmaceutical/biotechnology industry experience for Director level.
• Equivalent combination of education and experience may be considered.

Responsibilities

• Drive the end-to-end implementation of Manufacturing Execution Systems (MES) across biopharmaceutical facilities.
• Design and execute integration architectures connecting MES with Ignition, DeltaV, and Rockwell platforms.
• Contribute to the strategic vision of MES and manage its implementation across all IOPS sites.
• Develop strong business relationships with relevant stakeholder groups.
• Develop tailored frameworks for MES integration with various plant hubs and control systems.
• Establish master data architecture frameworks for system deployment.
• Manage complex validation requirements and change control processes.
• Transform paper-based batch records into compliant digital workflows.
• Diagnose and resolve integration challenges between disparate automation platforms.
• Redesign workflow processes to optimize operational efficiency and regulatory readiness.
• Provide guidance and support to MES team members.
• Lead and/or participate in projects and initiatives as assigned by management.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees