IT/OT Solutions Architect – GxP Manufacturing
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Job Description
Global IT/OT Solutions Architect designing secure, compliant manufacturing systems for FUJIFILM Biotechnologies. Connecting MES, automation, data, infrastructure, and cloud across worldwide sites.
Responsibilities:
- 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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