Reporting To: CDIO / SVP - Site Manufacturing Leader

Key Interfaces: Manufacturing, Engineering, Quality, IT, Data & Analytics, Supply Chain, OEMs, vendors, integrators.

Industry: Pharma Manufacturing (50 - 60% of Profile)

Technical Competencies:

- Manufacturing & Automation: PLC/DCS/SCADA, OT architecture, equipment integration, industrial networking.

- Applications: MES, EBR, Historian, Serialization, Track & Trace, LIMS/QMS.

- Enterprise Tech: SAP ERP, APIs, Cloud (Azure preferred), IT infra, networking.

- Data & Analytics: Architecture, governance, BI, advanced analytics, AI/ML, dashboards.

- Cybersecurity: IT/OT security, segmentation, vulnerability management, secure remote access.

- Regulatory: GMP/GxP, FDA, 21 CFR Part 11, EU Annex 11, CSV, Data Integrity.

Leadership Competencies: Strategic Thinking, Manufacturing Business Acumen, Digital Vision, IT/OT Integration, Systems Thinking, Stakeholder Management, Change Leadership, Innovation, Problem Solving, Influence Without Authority, Collaboration, Vendor Management, People Leadership.

Role Purpose: Drive end-to-end digital transformation of manufacturing operations by connecting plant equipment, automation/OT systems, manufacturing applications, enterprise IT, data platforms, analytics and AI into one integrated ecosystem. Ensure manufacturing assets and processes are digitally connected, data-driven, reliable, secure and compliant.

Key Responsibilities:

- Digital Manufacturing Strategy & Architecture: Develop enterprise/site roadmap, define target architecture, establish standards, leverage Industry 4.0, IoT/IIoT, AI/ML, Digital Twins, Edge, Cloud, predictive maintenance, real-time intelligence.

- Plant Automation & OT Connectivity: Lead PLC, DCS, SCADA/HMI, industrial networks, sensors, gateways, OT servers, alarm/event management, condition monitoring. Ensure secure, reliable data flow from equipment to enterprise systems.

- Manufacturing Systems: Own MES, EBR, Historian, Serialization, Track & Trace, Weigh & Dispense, QMS interfaces. Ensure integration, reliability, scalability, cybersecurity, lifecycle management.

- Manufacturing Data & Digital Thread: Establish strategy covering equipment, batch, production, quality, maintenance, energy, material, master data. Create single source of truth for manufacturing KPIs.

- Data, Analytics & AI: Drive productivity, OEE, yield, quality, throughput, reliability, energy efficiency, cost. Enable dashboards, KPI platforms, predictive analytics, anomaly detection, AI/ML use cases.

- Integration with SAP & Enterprise IT: Ensure seamless integration between OT-MES-SAP-Data Platform-Analytics. Translate manufacturing needs into scalable IT solutions.

- IT/OT Cybersecurity & Risk: Partner with CISO, enforce OT network security, access controls, vulnerability management, patching, secure remote access, segmentation, incident response, backup, disaster recovery.

- GMP/GxP/Data Integrity/Validation: Ensure compliance with FDA, 21 CFR Part 11, EU Annex 11, CSV, audits, inspections, lifecycle controls.

- Project Portfolio Management: Govern initiatives by business value, compliance, ROI, scalability. Lead projects from concept to benefits realization.

- Vendor & Integrator Management: Manage automation vendors, MES providers, integrators, cloud partners. Ensure delivery against standards, cybersecurity, validation, cost, performance.

- Business Partnership & Change Leadership: Act as digital partner for Manufacturing, Engineering, Quality, Supply Chain, Site Leadership. Drive adoption, change management, measurable operational improvement.