Solution Architect – IS&O Manufacturing

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Translate both business and technical requirements into comprehensive solution designs within the GxP Manufacturing sector.

• Create and maintain solution architecture documentation, which includes diagrams, data flows, interface definitions, and selections of technology.

• Assess whether initiatives fulfill the entry criteria for the Architecture Review Board and prepare necessary review materials.

• Conduct architecture impact evaluations across IT, OT, data, and security domains.

• Define and assess options for build-versus-buy, integration methods, and architectural patterns.

• Review designs to ensure they align with established patterns and reference architectures.

• Collaborate with engineering and delivery teams to clarify design intentions, address issues, and guarantee proper implementation.

• Identify and manage dependencies across teams, sequencing, and integration points.

• Integrate security, compliance, and infrastructure requirements into designs, considering GxP, identity, data protection, connectivity, and IT/OT segmentation.

• Confirm architecture dependencies, risks, and constraints to ensure readiness for release.

• Document and monitor architecture risks, exceptions, technical debt, and remediation strategies.

• Assist in decision-making for the ARB, escalating risks, conflicts, and deviations in design to the Solution Architecture Lead.

• Collaborate with enterprise architecture, cybersecurity, infrastructure, data, application, and site engineering teams.

• Enhance design quality and consistency, minimize rework, accelerate delivery, and boost inspection readiness.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Engineering, Information Systems, or a related field (or equivalent experience).

• Over 8 years of experience in manufacturing, OT, automation, or GxP solution architecture or engineering.

• Familiarity with MES, DCS/SCADA, historians, laboratory systems, and industrial integration patterns.

• Experience in designing IT/OT architectures, network segmentation, industrial DMZs, secure data flows, and resilient site solutions.

• Proven experience collaborating with Manufacturing, Automation, Quality/Validation, Security, Infrastructure, Data, and site engineering teams.

• Experience in environments regulated by GxP is required.

• Knowledge of ISA-95, ISA-88, and ISA/IEC 62443.

• Preferred certifications include ISA/IEC 62443 and TOGAF.

• Training or certification in ISA-95 / ISA-88 is a plus.

• GAMP 5 or GxP / Computer System Validation certification is also a plus.

• Strong expertise in GxP manufacturing technologies and architecture.

• Capability to design and document comprehensive end-to-end solutions and integrations.

• Understanding of inter-domain dependencies between IT, OT, security, and data.

• Strong analytical and problem-solving abilities.

• Effective communication skills and stakeholder engagement.

• Experience in global, cross-functional work environments.

• This role requires coordination across various time zones.

🏝️ Benefits

• Benefits and compensation are determined by the location of the employee’s home site.

• This is a global role with support across all FUJIFILM Biotechnologies sites.

• Occasional engagement outside of standard hours may be necessary.

• Equal opportunity in hiring, promotion, advancement, compensation, benefits, and training.

• Reasonable accommodations provided during the application and selection process.