Senior PAT Engineer

FUJIFILM Biotechnologies is looking for a Senior PAT Engineer to lead the design and integration of Process Analytical Technology solutions. This role involves collaborating with various departments to implement real-time monitoring and advanced process control, ensuring compliance with regulatory standards while driving technology transfer and process improvement.

Responsibilities:

• Architect and implement global PAT platforms and orchestrations (e.g., SynTQ, SIPAT) including connectivity frameworks, data pipelines, and model execution services to support development and commercial operations
• Integrate sensors/analyzers (e.g., Raman, NIR, FTIR, UV/Vis, conductivity, pH, DO, viable cell density) with DCS/MES/SCADA/Historian via interfaces such as OPC UA, ), ensuring robust, validated data flows
• Develop and maintain orchestrationsand support deployment of multivariate models (PCA/PLS, soft sensors) including calibration strategies, transfer methods, and model lifecycle governance aligned to cGxP
• Design and deploy feedback/feedforward APC strategies with Automation/MSAT (e.g., DeltaV, Rockwell) linking PAT outputs to control actions while maintaining safety, compliance, and process performance
• Establish governance (SOPs, WI, templates, RACI) for end-to-end PAT lifecycle: user requirements, design reviews, model management, change control, requalification, and retirement
• Execute CSV/CSA activities for PAT systems: URS/FRS authoring, risk assessments (GAMP 5), Part 11/Annex 11 controls, IQ/OQ/PQ, UAT, and documentation for audit readiness
• Implement data integrity (ALCOA+) and cybersecurity controls (ISA/IEC 62443) across PAT components and interfaces; partner with QA/IT/OT on periodic reviews and remediation
• Enable technology transfer by defining PAT strategies and readiness criteria
• Lead cross-functional workstreams and vendor engagements; plan deliverables, manage risks/issues, and communicate status/KPIs to stakeholders
• Troubleshoot PAT systems; lead root cause analyses, contribute to deviations/CAPAs, and implement preventive actions
• Drive training and change management for authors, operators, and engineers; create job aids and knowledge artifacts to accelerate adoption
• Harmonize master data, naming conventions, and ontologies for PAT signals, models, and parameters to improve interoperability and scalability across sites
• And other job duties that may be assigned from time to time

Requirements:

• Bachelors Degree in Engineering or Scientific related field
• 8+ years of relevant experience in biopharma manufacturing, MSAT, process development or automation/controls, including 2+ years implementing PAT systems and model-based controls (automation or integration)
• Demonstrated experience integrating analyzers/sensors with DCS/MES/SCADA and historians
• Proven experience in Computer System Validation
• Any combination of education and experience, which would provide an equivalent background to deliver against role expectations
• Platform expertise with SynTQ and/or SIPAT; familiarity with DeltaV, and OSIsoft PI