Principal Architect - IT, OT, GXP, GMP, LIMS - Hybrid, North East England
A large global organisation are 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.
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.
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.
Principal Architect - IT, OT, GXP, GMP, LIMS - Hybrid, North East England
Principal Architect - IT, OT, GXP, GMP, LIMS - Hybrid, North East Engl employer: MRP Technology Ltd
Join a forward-thinking company that values innovation and collaboration, offering a dynamic work culture in the heart of Cambridgeshire. As an SAP Travel Management Consultant, you'll benefit from competitive rates, flexible hybrid working arrangements, and ample opportunities for professional growth and development within a supportive team environment. With a focus on employee well-being and career advancement, this role provides a meaningful chance to contribute to significant projects while enhancing your expertise in SAP solutions.
