MRP-Global
Principal Architect - IT, OT, GXP, GMP, LIMS - Hybrid, North East of England
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Principal Architect
A large global organisation is seeking a Principal 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.
This will be worked on a hybrid basis, on site presence is required in the North East of England.
This will be an initial 6-12 months+ contract with the opportunity for extensions.
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.
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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.
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Desirable Knowledge
- 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.
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