Senior PAT Engineer

** Position Overview*
* The PAT Senior Engineer leads the design, integration, and lifecycle management of Process Analytical Technology (PAT) solutions across development and GMP manufacturing. Partnering with MSAT, Automation/Engineering, QA/CSV, and IT/OT, this role deploys sensors, analyzers, and models to enable real‑time monitoring, multivariate analytics, and advanced process control (APC). The incumbent establishes enterprise standards, orchestrations, and data flows that are compliant with cGxP and data integrity requirements, accelerating technology transfer, improving process robustness, and supporting Continued Process Verification (CPV).

Operates with minimal guidance and influences cross-functional stakeholders to harmonize practices and deliver business outcomes at network scale.

** Company Overview*
* The work we do at FUJIFILM Biotechnologies has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives.

Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

** Job Description*
* What you'll do:

+ 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/feed forward APC strategies with Automation/MSAT (e.g., Delta

V, 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 work streams 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.

What you'll need:

+ 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.

Preferred Requirements:

+ Platform expertise with SynTQ and/or SIPAT; familiarity with Delta

V, , and OSIsoft PI

Knowledge, Skills and Abilities:

+ Knowledge of integration architectures (ISA-95 layers), OPC UA, MQTT, and secure OT networking; exposure to ISA/IEC 62443 cybersecurity controls.

+ Solid understanding of cGMP/cGxP, data integrity, 21 CFR Part 11/Annex 11, GAMP 5, risk-based validation, and regulatory expectations for PAT and CPV.

+ Advanced knowledge of PAT platforms, analyzers, multivariate analytics, and control strategies; strong grasp of QbD, CPP/CQA mapping, and CPV.

+ Proficiency in automation/controls (Delta

V, Rockwell), integration (OPC UA, PI), and data…