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 update architecture diagrams, data flows, interface definitions, and select appropriate technologies.

• Evaluate initiatives against the criteria set by the Architecture Review Board and prepare necessary review documentation.

• Conduct architecture impact assessments across IT, OT, data, and security domains.

• Define and assess build-versus-buy options, architecture patterns, and integration strategies.

• Review designs to ensure compliance with approved patterns and reference architectures.

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

• Identify and manage dependencies, sequencing, and integration points across teams.

• Integrate GxP, identity, data protection, connectivity, infrastructure, and IT/OT segmentation requirements.

• Validate dependencies, risks, and constraints related to architecture prior to deployment.

• Document and monitor architecture risks, exceptions, technical debt, and remediation strategies.

• Assist in 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.

• Facilitate secure, scalable, resilient, and inspection-ready manufacturing solutions across global sites.

⛳️ 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 with MES, DCS/SCADA, historians, laboratory systems, and industrial integration patterns.

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

• Background in collaborating with Manufacturing, Automation, Quality/Validation, Security, Infrastructure, Data, and site engineering teams.

• Knowledge of ISA-95, ISA-88, and ISA/IEC 62443 standards.

• Experience in GxP-regulated environments is mandatory.

• Preferred certifications: ISA/IEC 62443 and TOGAF.

• ISA-95 / ISA-88 training or certification is a plus.

• GAMP 5 or GxP / Computer System Validation certification is advantageous.

• Ability to coordinate across global time zones and occasionally work outside regular hours.

• Strong expertise in GxP manufacturing technologies and architecture.

• Understanding of cross-domain dependencies and security-by-design principles.

• Excellent problem-solving and analytical skills.

• Proficient communication and stakeholder coordination in global, cross-functional environments.

🏝️ Benefits

• Benefits and compensation are determined by the employee's location and designated home site.

• Commitment to equal opportunities in compensation, benefits, and training.

• Provision of reasonable accommodations during the application and selection process.