Key Responsibilities
Lead the Digital Roadmap: Transition the factory from paper-based systems to a fully integrated "Smart Factory" (Pharma 4.0).
Manage IoT Integration: Deploy and maintain IIoT sensors to monitor production equipment and environment conditions in real-time.
Bridge IT & Operations: Connect shop-floor machinery (PLCs/SCADA) with high-level business systems (ERP/MES).
Ensure Regulatory Compliance: Maintain 100% "Audit Ready" status by following FDA 21 CFR Part 11 and GAMP 5 validation standards.
Guarantee Data Integrity: Enforce ALCOA+ principles to ensure all production data is accurate, permanent, and traceable.
Cybersecurity & Uptime: Protect intellectual property and ensure 24/7 network availability for the production lines.
Analyze Production Data: Use digital dashboards to track Yield and OEE (Overall Equipment Effectiveness).
Essential Requirements
Experience: 5+ years in IT, specifically within a GMP-regulated industry (Pharma, MedTech, or Biotech).
IoT Expertise: Proven experience connecting physical manufacturing hardware to digital cloud networks.
Compliance Knowledge: Solid understanding of Computer System Validation (CSV) and electronic records.
Tech Stack: Familiarity with ERP (like SAP), MES, LIMS, and IoT protocols (like OPC-UA or MQTT).
Education: Degree in IT, Automation Engineering, or a related technical field.