Principal Engineer, HighByte

Fujifilm Biotechnologies is seeking a Principal Engineer for the HighByte Intelligence Hub to lead the architecture and standards for manufacturing data solutions. The role involves defining enterprise standards, orchestrating data integration, and ensuring compliance 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)