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The Enterprise Architect is responsible for defining, governing, and evolving the site technology architecture for a pharmaceutical manufacturing facility operating in a regulated GxP environment. The role provides architectural leadership across IT, OT, automation, manufacturing execution, laboratory, quality, engineering, warehouse, serialisation, utilities, and enterprise systems to ensure technology supports safe, compliant, efficient, and resilient production. This position ensures that site digital manufacturing capabilities, validated systems, data flows, infrastructure, cybersecurity, integration patterns, and lifecycle roadmaps are aligned with business strategy, GMP expectations, product quality, patient safety, data integrity, inspection readiness, and site operational performance.
Develop and maintain site architecture vision, principles, standards, reference architectures, integration patterns, and roadmaps across IT, OT, automation, manufacturing, laboratory, quality, engineering, warehouse, serialisation, utilities, and enterprise platforms.
Translate site strategy, production priorities, product pipeline needs, quality requirements, engineering constraints, and regulatory expectations into target-state architectures and practical transition plans.
Provide architecture governance for site GxP systems, ensuring alignment with enterprise standards, site validation expectations, GMP controls, data integrity principles, cybersecurity requirements, and operational resilience needs.
Lead architectural direction for IT/OT convergence across pharmaceutical production environments, including integration between ERP, MES, LIMS, QMS, WMS, EDMS, serialisation systems, SCADA, DCS, PLC, historian, BMS, EMS, CMMS, weigh-and-dispense, electronic batch record, and equipment systems.
Define architecture patterns for validated manufacturing and laboratory systems, including electronic batch records, electronic signatures, audit trails, role-based access, segregation of duties, recipe and master data management, time synchronisation, backup, disaster recovery, and lifecycle controls.
Partner with Site Leadership, Quality Assurance, Quality Control, Manufacturing, Engineering, Automation, Validation, MSAT, Supply Chain, Cybersecurity, Infrastructure, Data, Application, and supplier teams to ensure technology decisions protect product quality, patient safety, data integrity, batch release, and compliance.
Support computerised system validation and computer software assurance by ensuring architecture artefacts, requirements, design decisions, risk assessments, traceability, test strategy, support model, and lifecycle controls are appropriate for regulated manufacturing use.
Assess the site IT/OT application, automation, network, server, endpoint, and integration landscape to identify compliance risks, obsolescence, technical debt, cyber exposure, unmanaged interfaces, manual transcription points, data integrity risks, and opportunities for simplification or modernisation.
Guide digital manufacturing, MES, electronic batch record, paperless operations, laboratory digitisation, quality digitalisation, process data historian, advanced analytics, AI, cloud, edge, and integration strategies in ways that are appropriate for validated site operations.
Shape site investment cases by assessing business value, compliance impact, production continuity, validation effort, operational risk, total cost of ownership, scalability, maintainability, lifecycle risk, and long-term platform health.
Facilitate site architecture review boards, design authorities, risk reviews, supplier design reviews, and cross-functional workshops for regulated technology change.
Maintain site architecture artefacts including capability maps, production system maps, data flow diagrams, system context diagrams, integration diagrams, site network and segmentation views, platform roadmaps, lifecycle plans, and architecture decision records.
Support audit and inspection readiness by ensuring architecture decisions, system ownership, supplier responsibilities, data flows, qualification assumptions, and operational controls are clearly documented and understood.
Promote consistent architecture practices and mentor solution architects, technical leads, automation engineers, system owners, and delivery teams working across site IT and OT domains.
Working knowledge of regulations and guidance relevant to computerised systems, electronic records, electronic signatures, batch records, and data integrity, such as EU GMP Annex 11, 21 CFR Part 11, GAMP 5, ALCOA+ principles, and MHRA data integrity expectations.
Broad technical understanding of pharmaceutical IT/OT architectures, ISA-95 or Purdue-style manufacturing models, industrial networks, segmentation, DMZ patterns, secure remote access, identity and access management, endpoint management, patching, backup, disaster recovery, monitoring, and site resilience.
Ability to define site target operating models, architecture principles, manufacturing capability maps, reference architectures, transition architectures, and practical delivery roadmaps that respect production constraints and validation effort.
Strong understanding of integration approaches across enterprise, manufacturing, laboratory, quality, warehouse, and shop-floor systems, including APIs, event-driven integration, middleware, ETL/ELT, OPC UA, historian integration, equipment interfaces, and master data flows.
Ability to balance compliance, cybersecurity, production continuity, validation effort, batch release impact, business value, technical risk, usability, supportability, and cost.
Excellent stakeholder management, communication, facilitation, influencing, and decision-framing skills, with the ability to translate between site operations, quality, engineering, automation, and corporate IT stakeholders.
Strong analytical thinking, systems thinking, problem-solving, risk-based decision-making, and root-cause-oriented improvement skills.
Ability to operate effectively in a live manufacturing environment where technology changes must be planned around production schedules, qualification windows, shutdowns, batch campaigns, and release priorities.
