Senior PAT Engineer
United States of America
Full-time
1 week ago
$120,000 - $198,000 USD
H1B Sponsor Likely
Key skills
Process Analytical Technology (PAT)Computer System Validation (CSV)Integration with DCS/MES/SCADAMultivariate analyticsData integrity (ALCOA+)Automation/controls DeltaVAutomation/controls RockwellStakeholder managementProject planningChange leadershipProblem-solvingAnalyticsLeadershipStakeholder ManagementChange ManagementCommunicationCollaboration
About this role
FUJIFILM Cellular Dynamics, Inc is a leader in biotechnologies, seeking a Senior PAT Engineer to lead the design and lifecycle management of Process Analytical Technology solutions. This role involves collaboration with various departments to implement real-time monitoring and advanced process control to improve manufacturing processes.
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
- 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 (DeltaV, Rockwell), integration (OPC UA, PI), and data modeling/ontologies for signals/parameters
- Expertise in CSV/CSA, data integrity, documentation, and audit preparation; ability to author URS/FRS and lead IQ/OQ/PQ/UAT
- Strong analytical and problem-solving skills; able to diagnose model/system issues and drive root cause and CAPA
- Excellent stakeholder management, communication, and change leadership; comfortable leading cross-functional teams through ambiguity
- Project planning and vendor management capabilities; ability to juggle multiple concurrent deployments
- Platform expertise with SynTQ and/or SIPAT; familiarity with DeltaV, and OSIsoft PI