GxP Enterprise Architect: IT/OT & Validation

Ekco; North East; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Flexible, family-friendly working

Career progression

Diversity, equality, inclusion & Belog

Job summary

Ekco is seeking an experienced Enterprise Architect to define and govern site technology architecture for a regulated pharmaceutical manufacturing facility. You will provide architectural leadership across IT, OT, automation, and quality systems to ensure compliant, efficient, and resilient operations.

Key focus areas include architecture governance for GxP systems, lifecycle planning, data integrity, and integration of ERP, MES, LIMS, QMS, and related platforms.

Qualifications

• Degree-level qualification in IT, Computer Science, Engineering or related discipline.
• Strong understanding of enterprise and site architecture frameworks (TOGAF, ArchiMate) and roadmapping.
• Experience with GxP, GMP, data integrity, and validation lifecycle principles.
• Ability to balance compliance, cybersecurity, production continuity, and cost.
• Excellent stakeholder management and communication skills.

Responsibilities

• Develop and maintain site architecture vision, standards, and roadmaps across IT/OT and enterprise platforms.
• Translate strategy and regulatory requirements into target-state architectures and transition plans.
• Provide architecture governance for GxP systems ensuring alignment with enterprise standards.
• Lead IT/OT convergence across production environments and integration between ERP/MES/LIMS/QMS/WMS.
• Define patterns for validated manufacturing and lab systems with proper security and lifecycle controls.
• Support audit readiness and risk reviews through architecture artefacts and documentation.

Skills

TOGAF

ArchiMate

Roadmapping

Stakeholder management

GxP/GMP knowledge

Education

Degree in IT/CS/Engineering

Tools

OPC UA

ERP/MES systems

Job description

Ekco is seeking an experienced Enterprise Architect to define and govern site technology architecture for a regulated pharmaceutical manufacturing facility. You will provide architectural leadership across IT, OT, automation, and quality systems to ensure compliant, efficient, and resilient operations.

Key focus areas include architecture governance for GxP systems, lifecycle planning, data integrity, and integration of ERP, MES, LIMS, QMS, and related platforms.