Global Solution Architect, GxP Manufacturing

FUJIFILM Holdings America Corporation

North Carolina

On-site

USD 170,000 - 260,000

Full time

14 days+
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Job summary

FUJIFILM Biotechnologies is seeking a Global Solution Architect (IS&O) for GxP Manufacturing to translate complex requirements into scalable architectures connecting shop floor to top floor—MES, DCS/SCADA, historians, labs, networks, and the cloud. The role emphasizes security, compliance, and global coordination across facilities to ensure compliant, reliable operations.

The ideal candidate brings 8+ years of manufacturing/OT/GxP architecture experience, strong IT/OT design skills, and

Qualifications

  • 8+ years in manufacturing, OT, automation, or GxP solution architecture.
  • Experience with MES, DCS/SCADA, historians, and lab systems.
  • Design IT/OT architectures with network segmentation and secure data flows.
  • Familiarity with ISA-95, ISA-88, and ISA/IEC 62443 in GxP environments.

Responsibilities

  • Translate business and technical requirements into end-to-end GxP Manufacturing designs and integration points.
  • Produce and maintain 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 and prepare required inputs for review.
  • Perform architecture impact assessments for new initiatives across IT, OT, data, and security domains.
  • Define and validate solution design options (e.g., build vs. buy) and support decision‑making with clear trade‑offs.
  • Review designs to ensure alignment with reference architectures; flag deviations for governance review.
  • Work with engineering/delivery teams to clarify design intent and ensure correct implementation.
  • Identify and manage cross‑team dependencies and planned integration points.
  • Ensure security, compliance and infrastructure requirements are embedded in designs (GxP, identity, data protection, connectivity).
  • Support release readiness by validating architecture dependencies/risks before deployment.
  • Document and track architecture risks, exceptions, and technical debt with mitigation plans.

Skills

GxP Manufacturing
IT/OT Architecture
Security-by-design
Cross-functional Collaboration
Global Coordination

Education

Bachelor's degree in Computer Science, Engineering, Information Systems, or related field

Tools

MES
DCS/SCADA
Historians
Labs systems

Job description

FUJIFILM Biotechnologies is seeking a Global Solution Architect (IS&O) for GxP Manufacturing to translate complex requirements into scalable architectures connecting shop floor to top floor—MES, DCS/SCADA, historians, labs, networks, and the cloud. The role emphasizes security, compliance, and global coordination across facilities to ensure compliant, reliable operations.

The ideal candidate brings 8+ years of manufacturing/OT/GxP architecture experience, strong IT/OT design skills, and

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