Global GxP Solution Architect — IT/OT Manufacturing

Merck & Co.; North Carolina; On-site; USD 150,000 - 190,000; Full time

Job summary

FUJIFILM Biotechnologies is hiring a Global Solution Architect (IS&O) for GxP Manufacturing to translate complex requirements into scalable designs connecting MES, DCS/SCADA, historians, labs, networks and cloud. The role emphasizes security, compliance, and rapid delivery to keep sites inspection-ready and safe.

You will own architecture artifacts, assess cross-domain impacts, define build-vs-buy options, and collaborate with engineering and delivery teams in a global, time-zone–span

Qualifications

• Bachelor's degree or equivalent experience in a related field.
• Experience with GxP manufacturing environments and validation.
• Strong understanding of IT/OT architectures and security-by-design.
• Experience in cross-functional global projects and audits.

Responsibilities

• Translate business and technical needs into end-to-end GxP solution designs (MES, DCS/SCADA, data flows, integration points).
• Produce and maintain architecture artifacts (diagrams, data flows, interface definitions, technology choices).
• Assess ARB entry criteria and prepare inputs for governance reviews.
• Evaluate architecture impact across IT, OT, data, and security domains.
• Define options (build vs. buy) with clear trade-offs and align with patterns.
• Ensure designs meet security, compliance, and infrastructure requirements.
• Collaborate with engineering to ensure correct implementation and delivery readiness.
• Identify cross-team dependencies and manage risks and timelines.

Skills

GxP manufacturing

IT/OT architecture

Security by design

Cross-functional collaboration

DCS/SCADA integration

Education

Bachelor's degree in CS/Engineering/IS

ISA/IEC 62443 (certified)

TOGAF (preferred)

ISA-95/ISA-88 training

GAMP 5 / GxP CV (nice-to-have)

Tools

MES

DCS/SCADA

Historians

Industrial networks

Job description

FUJIFILM Biotechnologies is hiring a Global Solution Architect (IS&O) for GxP Manufacturing to translate complex requirements into scalable designs connecting MES, DCS/SCADA, historians, labs, networks and cloud. The role emphasizes security, compliance, and rapid delivery to keep sites inspection-ready and safe.

You will own architecture artifacts, assess cross-domain impacts, define build-vs-buy options, and collaborate with engineering and delivery teams in a global, time-zone–span