Position OverviewArchitect the digital backbone of FUJIFILM Biotechnologies manufacturing. As our Global Solution Architect (IS&O) - GxP Manufacturing, you'll translate complex business and technical needs into practical, scalable architectures that connect shop floor to top floor-MES, DCS/SCADA, historians, labs, networks, and the cloud. Your work will hardwire security and compliance into every design, accelerate delivery, and ensure our sites run safely, reliably, and inspection-ready. Join us to shape solutions that protect patients, empower operators, and enable confident growth across our global network.
Job DescriptionWhy this role matters- Build once, scale everywhere: Create end-to-end designs that harmonize IT/OT, secure data flows, and enable resilient site operations across multiple facilities and modalities.
- Raise the bar on compliance and speed: Surface risks and dependencies early, align to enterprise patterns, and get solutions release-ready with fewer surprises and less rework.
- Protect what matters: By embedding GxP, ISA/IEC 62443, and industry standards into every solution, you'll reduce compliance exposure and strengthen reliability and security for clients and patients.
What you'll do:- Translate business and technical requirements into end-to-end solution designs within the GxP Manufacturing domain, including system interactions, data flows, and integration points.
- Produce and maintain solution architecture artifacts (diagrams, data flows, interface definitions, technology selections) to support design decisions and delivery teams.
- Identify whether initiatives meet Architecture Review Board (ARB) entry criteria (e.g., cross-domain impact, regulatory scope, new technology, high-risk design) and prepare required inputs for review.
- Perform architecture impact assessments for new initiatives, including dependencies across IT, OT, data, and security domains.
- Define and validate solution design options (e.g., build vs. buy, pattern selection, integration approaches) and support decision-making with clear trade-offs.
- Review designs to ensure alignment with approved patterns and reference architectures; flag and route deviations for governance review.
- Work closely with engineering and delivery teams to clarify design intent, resolve design issues, and ensure correct implementation of the architecture.
- Identify and manage cross-team dependencies, ensuring sequencing and integration points are clearly understood and planned.
- Ensure security, compliance, and infrastructure requirements are embedded in solution designs (e.g., GxP, identity, data protection, connectivity, IT/OT segmentation).
- Support release readiness by validating that architecture-related dependencies, risks, and constraints are addressed prior to deployment.
- Document and track architecture risks, exceptions, and technical debt, including mitigation or remediation plans.
- And other job duties as assigned.
Minimum education requirements- Bachelor's degree in Computer Science, Engineering, Information Systems, or related field (or equivalent experience).
Preferred certifications- ISA/IEC 62443
- TOGAF
- ISA-95 / ISA-88 training or certification (nice-to-have)
- GAMP 5 or GxP / Computer System Validation certification (nice-to-have)
Minimum experience requirements- 8+ years in manufacturing, OT, automation, or GxP solution architecture or engineering.
- Experience with manufacturing platforms and systems, including MES, DCS/SCADA, historians, laboratory systems, and industrial integration patterns.
- Experience designing IT/OT architectures, network segmentation, industrial DMZs, secure data flows, and resilient site solutions.
- Experience working with Manufacturing, Automation, Quality/Validation, Security, Infrastructure, Data, and site engineering teams.
- Familiarity with ISA-95, ISA-88, and ISA/IEC 62443; experience in GxP-regulated environments required.
How you'll operate- Own architecture input and design quality within the GxP Manufacturing domain; support ARB decision-making inputs.
- Identify dependencies, risks, and complexity across initiatives; escalate risks, conflicts, and design deviations to the Solution Architecture Lead as needed.
- Interface with Solution Architecture Lead, Enterprise Architecture, cybersecurity, infrastructure, data, and application teams; align with enterprise standards while balancing delivery constraints.
- Global role requiring coordination across time zones; occasional off-hours engagement as needed.
What you'll bring- Strong expertise in GxP manufacturing technologies and architecture, with the ability to design and document end-to-end solutions and integrations.
- Understanding of cross-domain dependencies (IT, OT, security, data) and how to embed security-by-design.
- Strong problem-solving and analytical skills; clear articulation of risks, options, and trade-offs.
- Effective communication and stakeholder coordination; experience working in global, cross-functional environments.
Your impact from day one- Increase design quality and consistency across manufacturing initiatives-reducing rework, speeding delivery, and improving inspection readiness.
- Provide clear governance inputs and ready-for-release solutions that are secure, scalable, and resilient.
- Enable digital capabilities that let FLBG manufacture and release with confidence-safely, quickly, and at global scale.
This is a global position that will support all our FUJIFILM Biotechnologies 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.
