IT/OT Solutions Architect - GxP Manufacturing

FUJIFILM; North Carolina; Remoto; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

FUJIFILM Biotechnologies is seeking a Global Solution Architect (IS&Os—GxP Manufacturing) to design end-to-end manufacturing solutions from shop floor to cloud. You’ll ensure compliant, secure, scalable architectures spanning MES, DCS/SCADA, historians, and labs, while coordinating globally across time zones.

You will translate complex requirements into architecture artifacts, review designs, and guide delivery teams to release-ready solutions that optimize reliability and speed across sites.

Competenze

• Bachelor’s degree in Computer Science, Engineering, Information Systems, or related field.
• 8+ years in manufacturing, OT, automation, or GxP solution architecture or engineering.
• Experience with MES, DCS/SCADA, historians, and lab systems.

Mansioni

• Translate business and technical requirements into end-to-end solutions within GxP Manufacturing.
• Produce architecture artifacts to support design decisions and delivery teams.
• Assess architecture risks, dependencies, and alignment to enterprise standards.
• Ensure security, compliance, and data protection are embedded in designs.
• Collaborate with engineering, cybersecurity, and infrastructure teams.

Conoscenze

Solution Architecture

IT/OT Integration

Security-by-design

Cross-functional collaboration

Formazione

Bachelor’s degree in Computer Science, Engineering, Information Systems

Strumenti

MES

DCS/SCADA

Laboratory systems

Descrizione del lavoro

Position Overview

Architect 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.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Why 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; elevate 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.

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organization is committed to being transparent about how it collects and uses that data and 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.

EEO Information

Fujifilm is committed to 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 ([e-mail]).