IT/OT Solutions Architect – GxP Manufacturing

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina – Remote

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⏰ Full Time

🟠 Senior

🔴 Lead

💻 Solutions Engineer

👻 Ghost score 10%

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Logo of FUJIFILM Corporation

FUJIFILM Corporation

10,000+ employees

Founded 1934

🏭 Manufacturing

🏥 Healthcare

Manufacturing • Healthcare • Electronics

FUJIFILM Corporation is a global company established in 1934, operating in diverse fields including healthcare, electronics, and imaging. As a total healthcare company, FUJIFILM develops a wide range of businesses in prevention, diagnosis, and treatment. Additionally, the company focuses on environmental sustainability through improved industrial efficiency, while also capturing and preserving memories through film and photography, enriching emotional lives and human connections.

📋 Description

• Translate business and technical requirements into end-to-end solution designs for GxP Manufacturing • Produce and maintain architecture diagrams, data flows, interface definitions, and technology selections • Assess initiatives against Architecture Review Board entry criteria and prepare review inputs • Perform architecture impact assessments across IT, OT, data, and security domains • Define and validate build-versus-buy options, architecture patterns, and integration approaches • Review designs for alignment with approved patterns and reference architectures • Collaborate with engineering and delivery teams to clarify design intent and resolve implementation issues • Identify and manage cross-team dependencies, sequencing, and integration points • Embed GxP, identity, data protection, connectivity, infrastructure, and IT/OT segmentation requirements • Validate architecture dependencies, risks, and constraints before deployment • Document and track architecture risks, exceptions, technical debt, and remediation plans • Support ARB decision-making and escalate risks, conflicts, and design deviations to the Solution Architecture Lead • Coordinate with enterprise architecture, cybersecurity, infrastructure, data, and application teams • Enable secure, scalable, resilient, and inspection-ready manufacturing solutions across global sites

🎯 Requirements

• Bachelor’s degree in Computer Science, Engineering, Information Systems, or related field, or equivalent experience • 8+ years in manufacturing, OT, automation, or GxP solution architecture or engineering • Experience with 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 • Preferred certifications: ISA/IEC 62443 and TOGAF • ISA-95 / ISA-88 training or certification is nice-to-have • GAMP 5 or GxP / Computer System Validation certification is nice-to-have • Ability to coordinate across global time zones and occasionally engage outside regular hours • Strong expertise in GxP manufacturing technologies and architecture • Understanding of cross-domain dependencies and security-by-design • Strong problem-solving and analytical skills • Effective communication and stakeholder coordination in global, cross-functional environments

🏖️ Benefits

• Benefits and compensation governed by the location where the employee is based and considered their home site • Equal opportunities in compensation, benefits, and training • Reasonable accommodation during the application and selection process

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