Global Solution Architect (IS&O) - GxP Manufacturing
Architect the digital backbone of FLBG manufacturing. As our Global Solution Architect (IS&O) - GxP Manufacturing, you’ll translate complex business and technical needs into practical, scalable architectures that connect shop floor to top floor-MES, DCS/SCADA, historians, labs, networks, and the cloud. Your work will hardwire security and compliance into every design, accelerate delivery, and ensure our sites run safely, reliably, and inspection-ready. Join us to shape solutions that protect patients, empower operators, and enable confident growth across our global network.
Why this role matters
Build once, scale everywhere: Create end-to-end designs that harmonize IT/OT, secure data flows, and enable resilient site operations across multiple facilities and modalities.
Raise the bar on compliance and speed: Surface risks and dependencies early, align to enterprise patterns, and get solutions release-ready with fewer surprises and less rework.
Protect what matters: By embedding GxP, ISA/IEC 62443, and industry standards into every solution, you’ll reduce compliance exposure and strengthen reliability and security for clients and patients.
What you’ll do
- Translate business and technical requirements into end-to-end solution designs within the GxP Manufacturing domain, including system interactions, data flows, and integration points.
- Produce and maintain solution architecture artifacts (diagrams, data flows, interface definitions, technology selections) to support design decisions and delivery teams.
- Identify whether initiatives meet Architecture Review Board (ARB) entry criteria (e.g., cross-domain impact, regulatory scope, new technology, high-risk design) and prepare required inputs for review.
- Perform architecture impact assessments for new initiatives, including dependencies across IT, OT, data, and security domains.
- Define and validate solution design options (e.g., build vs. buy, pattern selection, integration approaches) and support decision-making with clear trade-offs.
- Review designs to ensure alignment with approved patterns and reference architectures; flag and route deviations for governance review.
- Work closely with engineering and delivery teams to clarify design intent, resolve design issues, and ensure correct implementation of the architecture.
- Identify and manage cross-team dependencies, ensuring sequencing and integration points are clearly understood and planned.
- Ensure security, compliance, and infrastructure requirements are embedded in solution designs (e.g., GxP, identity, data protection, connectivity, IT/OT segmentation).
- Support release readiness by validating that architecture-related dependencies, risks, and constraints are addressed prior to deployment.
- Document and track architecture risks, exceptions, and technical debt, including mitigation or remediation plans.
- And other job duties as assigned.
Minimum education requirements
- Bachelor’s degree in Computer Science, Engineering, Information Systems, or related field (or equivalent experience).
Preferred certifications
- ISA/IEC 62443 TOGAF ISA-95 / ISA-88 training or certification (nice-to-have)
- GAMP 5 or GxP / Computer System Validation certification (nice-to-have)
Minimum experience requirements
- 8+ years 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.
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