Senior PAT Engineer

PAT Senior Engineer

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.

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 orchestrations and 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.

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.

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!