Director of IT - OT Manufacturing

About the role

You will lead with purpose—driving innovation at the intersection of manufacturing, digital technology, and patient impact. This role is a pivotal leadership position within a newly forming standalone organization, responsible for building and scaling modern Manufacturing IT capabilities that enable speed, quality, and compliance.

Responsibilities

• Own end-to-end Manufacturing IT across multiple sites (Juncos, PR and Northridge, CA).
• Lead the convergence of IT and OT environments, including PLCs, machine integration, and shop floor systems.
• Ensure resilient, secure, and compliant operation of all manufacturing systems supporting production.
• Serve as the single point of accountability for manufacturing technology performance and uptime.
• Lead the strategy, deployment, and lifecycle management of MES (Factoryworks & Process Integration or similar) platforms.
• Drive MES standardization across sites, including data models, workflows, and integration patterns.
• Oversee end-to-end MES implementations, upgrades, and expansions aligned to business growth.
• Ensure MES supports traceability, genealogy, and regulatory compliance (GxP, FDA).
• Define and implement scalable architectures connecting: PLCs / equipment controllers, MES platforms, Enterprise systems (SAP ECC / S4), Data and analytics platforms.
• Lead development of modern integration patterns (APIs, middleware, event-driven architectures).
• Enable real-time manufacturing visibility and analytics through robust data pipelines.
• Oversee L1–L3 support models for all manufacturing systems.
• Establish SLAs, KPIs, and monitoring for system reliability and performance.
• Drive proactive incident management and root cause elimination.
• Ensure audit readiness and compliance with GxP, cybersecurity, and validation standards.
• Build and lead a high-performing, multi-site Manufacturing IT organization.
• Develop talent across IT and OT domains, fostering cross-functional expertise.
• Manage strategic partners and system integrators for MES and automation delivery.
• Create a culture of accountability, responsiveness, and continuous improvement.
• Lead initiatives in: Smart manufacturing / Industry 4.0, Automation and robotics integration, Advanced analytics and shop floor intelligence.
• Identify opportunities to reduce manual processes and improve throughput, quality, and compliance.
• Partner with manufacturing, quality, and engineering to align technology with business outcomes.

Requirements

• Requires a bachelor’s degree and minimum of 10 years of relevant experience and 7+ years of managerial experience, or advanced degree with a minimum of 8 years relevant experience and 7+ years of managerial experience.
• Bilingual (Spanish and English)
• Preferred Experience:
  • Master’s degree
  • 10+ years of experience in IT, with significant depth in manufacturing environments.
  • 7+ years of leadership experience managing global or multi-site teams.
  • Proven track record of leading MES implementations at scale.
  • Expertise in SCADA, PLCs, OPC-UA gateways, historians (OSIsoft PI), and ERP integration.
  • Strong understanding of ISA-95 architecture, system validation (CSV), and latency mitigation strategies.
  • Deep knowledge of cGMP, ISO 13485, FDA 21 CFR Part 11, and data integrity principles.
  • Experience with data analytics platforms (Power BI, Tableau, or similar), predictive modeling, and machine learning for manufacturing.
  • Knowledge of automation systems (robots, vision, feeders) and their role in validated processes.
  • Strong experience with enterprise integration (SAP ECC / S4).
  • Hands-on experience with FactoryWorks or similar MES platforms.
  • Experience in medical device, life sciences, or regulated consumer products manufacturing.
  • Exposure to automation, robotics, and smart factory initiatives.
  • Familiarity with validation (CSV), data integrity, and audit processes.

Why This Role Matters

Lead the digital backbone of manufacturing in a newly independent, high-growth organization. Shape the future-state architecture of MES and IT/OT integration. Directly impact product quality, compliance, and patient outcomes. Build and scale a modern Manufacturing IT organization from the ground up.