FUJIFILM Biotechnologies is seeking a Principal Engineer for Unified Namespace Architecture to lead the development of high-performance manufacturing data solutions. This role involves defining enterprise standards, governing the HighByte platform, and orchestrating data integration across various systems to enhance analytics and decision-making in regulated environments.
Responsibilities:
- Lead strategy and roadmaps: Advise on Industry 4.0 and manufacturing data strategies; develop multi‑year roadmaps for UNS, event‑driven architectures, OT/IT convergence, and cloud/hybrid patterns
- Define enterprise standards: Establish ISA‑95/ISA‑88‑aligned contextualization models, topic hierarchies, naming conventions, and canonical payload standards to ensure interoperability and reusability
- Own the HighByte platform: Govern standards, configurations, lifecycle, change control, documentation, versioning, scalability, and platform health
- Orchestrate data integration: Design and guide Industrial DataOps pipelines across PLC/SCADA/DCS, historians, MES/LIMS/QMS/CMMS/ERP, cloud data platforms, and APIs
- Embed compliance by design: Apply GAMP5/CSA, CSV deliverables (URS, risk, testing, traceability), and ALCOA+ data integrity; support audits/inspections and CAPAs
- Monitor performance: Define and track KPIs (latency, throughput, reliability, schema adherence); implement observability and alerting for UNS and pipelines
- Manage risk: Identify architectural risks, technical debt, and deviations; lead trade‑off analyses and mitigation plans
- Translate and deliver: Convert business needs into designs; produce architecture artifacts; coordinate with internal teams and vendors; enable change readiness and knowledge transfer
- Enable people and partners: Liaise with Manufacturing, QA/ITQ, Automation/OT, Cybersecurity, Enterprise Architecture, and external SIs; build playbooks and training
- Innovate and improve: Evaluate edge, streaming, and schema registry patterns; pilot and scale improvements that enhance reliability, compliance, and analytics outcomes
Requirements:
- Bachelor's degree in Engineering, Computer Science, Data Science, or related field; or an equivalent combination of education and experience
- Typically 12+ years of related experience with a Bachelor's; or 8+ years with a Master's; or PhD with 5+ years; or equivalent experience
- Within the above, 6+ years in Industry 4.0/manufacturing data, including OT environments, historians, IT/OT integration, and cloud/hybrid infrastructure
- Strong hands‑on experience with HighByte Intelligence Hub, UNS architectures, and ISA‑95/ISA‑88‑aligned data models in regulated life‑sciences or comparable industries
- Experience with platform monitoring and lifecycle management
- Experience with DataOps and streaming frameworks (MQTT/Kafka/AMQP), schema registries, and integration tooling
- Familiarity with FAIR data principles; data quality, lineage, and observability tooling
- Validation expertise (GAMP5/CSA, CSV deliverables); audit/inspection support experience
- Cloud data platforms and analytics integration (e.g., Azure/AWS/GCP services)
- Relevant certifications in data/architecture/OT (e.g., ISA/IEC), and project or Agile methods (PMP/PRINCE2/Scrum)