IT/OT Solutions Architect – GxP Manufacturing

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Convert business and technical specifications into comprehensive solution designs for GxP Manufacturing.

• Create and uphold solution architecture documentation, which includes diagrams, data flows, interface definitions, and technology selections.

• Evaluate Architecture Review Board entry criteria and prepare necessary review materials.

• Conduct architecture impact evaluations across IT, OT, data, and security sectors.

• Determine and confirm build-versus-buy choices, patterns, and integration methods.

• Assess designs for conformity with sanctioned patterns and reference architectures.

• Collaborate with engineering and delivery teams to elucidate design intentions and address design challenges.

• Identify and oversee cross-team dependencies, sequencing, and integration points.

• Integrate security, compliance, and infrastructure requirements into designs, encompassing GxP, identity, data protection, connectivity, and IT/OT segmentation.

• Assist in release readiness by verifying architecture dependencies, risks, and constraints.

• Document and monitor architecture risks, exceptions, and technical debt along with mitigation strategies.

• Aid in ARB decision-making and escalate risks, conflicts, and design deviations to the Solution Architecture Lead.

• Liaise with enterprise architecture, cybersecurity, infrastructure, data, application, and site engineering teams.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Engineering, Information Systems, or a related field (or equivalent experience).

• Over 8 years of experience in manufacturing, OT, automation, or GxP solution architecture or engineering.

• Proficiency in MES, DCS/SCADA, historians, laboratory systems, and industrial integration frameworks.

• Experience in designing IT/OT architectures, network segmentation, industrial DMZs, secure data flows, and resilient site solutions.

• Proven track record of working with Manufacturing, Automation, Quality/Validation, Security, Infrastructure, Data, and site engineering teams.

• Familiarity with ISA-95, ISA-88, and ISA/IEC 62443 standards.

• Experience in environments regulated by GxP.

• Preferred certifications include ISA/IEC 62443 and TOGAF.

• In-depth knowledge of GxP manufacturing technologies and architecture.

• Excellent problem-solving and analytical abilities.

• Strong communication skills and the ability to coordinate with stakeholders in global, cross-functional contexts.

• Capability to coordinate across different time zones and engage occasionally outside of standard working hours.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness benefits.

• Flexible work arrangements and a supportive work environment.