Senior PAT Engineer

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: $ 120000 - 198000

Posted on: 7 days ago

Vacancies: 1 Vacancy

Job Summary

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 realtime 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 importantand 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 peoples 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 70000 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: Description

What youll 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/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 youll 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 DeltaV 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 (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.

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 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!

The US salary range for this position is $120000 to $198000. Pay within this range varies by work locationand may also depend on job-related knowledge skillsand experience.

As part of any recruitment process FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. Theorganization is committed to beingtransparent about how it collects and uses that dataand to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

This is a global position that will support all our sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior IC

Position OverviewThe 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 ena...