Director, MES Implementation & Integration

Role Summary

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 develop and implement 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.

Responsibilities

• Contribute to the strategic vision of MES and lead the implementation and integration of the MES system across all manufacturing sites, while developing strong business relationships with stakeholder groups to attain a solid understanding of their goals and objectives.
• 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 mentorship and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals.

Qualifications

• 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 while enabling operational efficiency improvements through integrated system capabilities.
• Deep expertise addressing integration challenges across different automation platforms and system architectures. Proven ability diagnosing complex technical problems and implementing solutions under timeline pressure while maintaining quality and compliance standards.
• BS degree in life sciences, computer science or engineering or related field; Associate Director: 10+ years; Director: 12+ years in pharmaceutical/biotechnology industry. May consider equivalent combination of education and experience.

Skills

• MES implementation and integration
• FDA regulatory compliance
• System architecture and data governance
• Validation and change control
• Cross-platform integration (Ignition, DeltaV, Rockwell)
• Leadership and mentorship

Education

• Bachelor‚Äôs degree in life sciences, computer science, engineering, or related field (relevant advanced degrees may be considered)

Additional Requirements

• None