IT/OT Solutions Architect - GxP Manufacturing

Fujifilm•Morrisville, NC

69d

About The Position

The IT/OT Solutions Architect — GxP Manufacturing will architect end-to-end solutions connecting manufacturing-floor systems and enterprise capabilities, including MES, DCS/SCADA, historians, laboratories, networks, and cloud services. The role translates business and technical needs into practical, scalable designs that support safe, reliable, secure, and inspection-ready operations across FUJIFILM Biotechnologies’ global sites. The architect embeds GxP, security, compliance, and applicable industry standards into solution designs; produces architecture artifacts; assesses impacts, dependencies, risks, and design options; and supports governance and release readiness. The role works closely with engineering and delivery teams and coordinates across manufacturing, automation, quality and validation, security, infrastructure, data, application, and site engineering teams. This is a global position supporting all FUJIFILM Biotechnologies sites and can be based at any company location worldwide. Benefits and compensation depend on the location designated as the home site. Occasional off-hours engagement may be needed to coordinate across time zones.

Requirements

Bachelor’s degree in Computer Science, Engineering, Information Systems, or a related field, or equivalent experience.
At least 8 years of experience 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.
Expertise in GxP manufacturing technologies and architecture, including the ability to design and document end-to-end solutions and integrations.
Understanding of cross-domain dependencies across IT, OT, security, and data, and how to embed security by design.
Strong problem-solving and analytical skills, with the ability to clearly articulate risks, options, and trade-offs.
Effective communication and stakeholder coordination skills, including experience in global, cross-functional environments.

Nice To Haves

ISA/IEC 62443 certification.
TOGAF certification.
ISA-95 or ISA-88 training or certification.
GAMP 5 or GxP/Computer System Validation certification.

Responsibilities

Translate business and technical requirements into end-to-end solution designs in the GxP Manufacturing domain, including system interactions, data flows, and integration points.
Produce and maintain architecture artifacts, including diagrams, data flows, interface definitions, and technology selections.
Determine whether initiatives meet Architecture Review Board (ARB) entry criteria and prepare required review inputs.
Assess architecture impacts and dependencies across IT, OT, data, and security domains.
Define and validate design options, such as build-versus-buy choices, architecture patterns, and integration approaches, and explain their trade-offs.
Review designs for alignment with approved patterns and reference architectures; flag and route deviations for governance review.
Work with engineering and delivery teams to clarify design intent, resolve design issues, and support correct architecture implementation.
Identify and manage cross-team dependencies, including sequencing and integration points.
Embed security, compliance, and infrastructure requirements in designs, including GxP, identity, data protection, connectivity, and IT/OT segmentation.
Support release readiness by validating that architecture-related dependencies, risks, and constraints are addressed before deployment.
Document and track architecture risks, exceptions, and technical debt, including mitigation or remediation plans.
Own architecture input and design quality within the GxP Manufacturing domain and support ARB decision-making inputs.
Escalate risks, conflicts, and design deviations to the Solution Architecture Lead as needed.
Coordinate with the Solution Architecture Lead, Enterprise Architecture, cybersecurity, infrastructure, data, and application teams, aligning with enterprise standards while balancing delivery constraints.
Perform other job duties as assigned.