Enterprise Architect - IT, OT, GXP, GMP, LIMS - 100% Remote

MRP Global; United States; Remote; GBP 90,000 - 130,000; Full time

Job summary

MRP Global is seeking an Enterprise Architect to define and govern the technology architecture for a manufacturing site operating within a regulated environment.

You will lead IT and OT architecture across ERP, MES, LIMS, QMS, WMS, SCADA, DCS and laboratory systems, ensuring compliance with GxP, GMP, data integrity and cybersecurity while driving digital manufacturing and operational resilience. This is a 100% remote contract.

Qualifications

• Significant enterprise, solution or site architecture experience within regulated manufacturing environments.
• Strong experience across IT and OT technologies within manufacturing.
• Knowledge of GxP, GMP, computerised system validation, data integrity, change control and inspection readiness.
• Experience with platforms such as ERP, MES, LIMS, QMS, WMS, eBR/eBMR, SCADA, DCS, PLCs, historians, BMS or CMMS.
• Proven experience developing technology roadmaps, reference architectures, integration patterns and governance frameworks.
• Excellent stakeholder-management skills across technical, operational, quality and senior leadership teams.
• TOGAF/ArchiMate/ISA-95/ISA-88 or Purdue architecture models.
• EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+.
• IEC 62443, ISO 27001, NIST, ITIL, Agile or SAFe.

Responsibilities

• Define and govern the site technology architecture, standards, roadmaps and integration strategy.
• Lead architecture across IT/OT environments and platforms including ERP, MES, LIMS, QMS, WMS, SCADA, DCS, PLCs, historians and laboratory systems.
• Ensure solutions align with GxP, GMP, data-integrity, validation and cybersecurity requirements.
• Assess the existing technology landscape, identifying compliance risks, obsolescence, technical debt and modernisation opportunities.
• Support digital manufacturing, paperless production, electronic batch records, laboratory digitisation and OT transformation initiatives.
• Lead architecture reviews and collaborate with Quality, Manufacturing, Engineering, Automation, Validation, Cybersecurity and Infrastructure teams.
• Support audit and inspection readiness through clear architecture documentation and governance.
• Engage with external vendors, system integrators, automation partners and global enterprise teams.

Skills

Enterprise architecture

IT/OT convergence

GxP GMP familiarity

Stakeholder management

Education

Degree in IT/CS/Engineering/Automation

Tools

TOGAF

ArchiMate

ISA-95/ISA-88

Purdue model

Job description

A large global organisation are seeking a Enterprise Architect to define and govern the technology architecture for a manufacturing site operating within a regulated environment.

This role will provide architectural leadership across IT, OT, automation, manufacturing, laboratory, quality, engineering and supply-chain systems. You will ensure the site's technology landscape supports compliant, secure, resilient and efficient manufacturing operations.

The role will be worked on a 100% remote basis.

This will be an initial contract of up to six months, with the overall project expected to run until late 2027.

Key Responsibilities:

• Define and maintain the site technology architecture, standards, roadmaps and integration strategy.
• Lead architecture across IT/OT environments and platforms including ERP, MES, LIMS, QMS, WMS, SCADA, DCS, PLCs, historians and laboratory systems.
• Ensure solutions align with GxP, GMP, data-integrity, validation and cybersecurity requirements.
• Assess the existing technology landscape, identifying compliance risks, obsolescence, technical debt and modernisation opportunities.
• Support digital manufacturing, paperless production, electronic batch records, laboratory digitisation and OT transformation initiatives.
• Lead architecture reviews and collaborate with Quality, Manufacturing, Engineering, Automation, Validation, Cybersecurity and Infrastructure teams.
• Support audit and inspection readiness through clear architecture documentation and governance.
• Engage with external vendors, system integrators, automation partners and global enterprise teams.

Required Experience:

• Significant enterprise, solution or site architecture experience within pharmaceutical, biotechnology, life sciences or another highly regulated manufacturing environment.
• Strong experience across both IT and OT technologies within a manufacturing setting.
• Knowledge of GxP, GMP, computerised system validation, data integrity, change control and inspection readiness.
• Experience with pharmaceutical platforms such as ERP, MES, LIMS, QMS, WMS, eBR/eBMR, SCADA, DCS, PLCs, historians, BMS or CMMS.
• Proven experience developing technology roadmaps, reference architectures, integration patterns and governance frameworks.
• Strong knowledge of digital manufacturing, system modernisation, IT/OT convergence and operational resilience.
• Excellent stakeholder-management skills, with the ability to communicate effectively across technical, operational, quality and senior leadership teams.
• TOGAF, ArchiMate, ISA-95, ISA-88 or Purdue architecture models.
• EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+.
• IEC 62443, ISO 27001, NIST, ITIL, Agile or SAFe.
• Degree in IT, Computer Science, Engineering, Automation or a related discipline.