OT Architect - OutsideIR35

OT Architect - OutsideIR35

Contract: 6 Months
IR35: OUTSIDE IR35
Location: REMOTE - UK
On-site: 1 day per month (North Yorkshire)
Industry: Pharmaceutical / Life Sciences
Engagement: Contract
Rate: 450pd+ Outside

The Opportunity

We are working with a pharmaceutical manufacturing organisation undergoing a significant transformation across its IT, OT, automation and digital manufacturing environment.

They are looking for an experienced OT Architect to provide architectural leadership across a highly regulated pharmaceutical manufacturing environment, helping to define how IT, OT, automation, manufacturing systems, infrastructure, cybersecurity and enterprise platforms come together.

This is a genuine Outside IR35 contract, offering predominantly remote working with only 1 day per month on-site.

The successful candidate will operate at an architectural level, working across both strategic and technical domains to define target-state architecture, integration patterns, technology standards, roadmaps and governance across the manufacturing environment.

Key Responsibilities

• Define and maintain the OT and site architecture vision, principles, standards, reference architectures and technology roadmaps.
• Provide architectural leadership across pharmaceutical manufacturing, including OT, automation, MES, SCADA, DCS, PLCs, historians, BMS, EMS, laboratory systems and enterprise platforms.
• Define and govern IT/OT convergence and integration architectures across manufacturing and corporate environments.
• Develop target-state architectures and practical transition roadmaps that consider production requirements, regulatory obligations, cybersecurity, resilience and lifecycle management.
• Work across platforms including MES, LIMS, QMS, WMS, ERP, EDMS, serialisation, CMMS, electronic batch records and shop-floor systems.
• Define secure and resilient architectures covering industrial networks, segmentation, DMZs, remote access, identity, infrastructure, servers, endpoints, monitoring, backup and disaster recovery.
• Assess existing OT environments to identify technical debt, obsolescence, cyber risk, unsupported technologies, architectural weaknesses, unmanaged interfaces and resilience gaps.
• Develop architecture patterns for validated and regulated manufacturing systems, including audit trails, electronic signatures, role-based access, segregation of duties, data integrity, master data, time synchronisation and lifecycle controls.
• Ensure architectural decisions support GMP, GxP, data integrity, patient safety, product quality and inspection readiness.
• Partner with Engineering, Automation, Manufacturing, Quality, Validation, Cybersecurity, Infrastructure, Data, Applications and senior site stakeholders.
• Support CSV/CSA, validation, risk assessments, design reviews, change control and regulated technology implementation.
• Lead architecture workshops, design authorities, technical reviews and supplier design assessments.
• Maintain architecture documentation including system landscapes, capability maps, data flows, integration diagrams, network/segmentation views, roadmaps and architecture decision records.
• Provide architectural input into technology investment cases, assessing business value, production impact, compliance, risk, lifecycle, scalability, supportability and total cost of ownership.
• Support digital manufacturing initiatives involving cloud, edge computing, advanced analytics, AI, automation and industrial data platforms, where appropriate for a validated environment.
• Help establish consistent architecture practices across OT, engineering, automation and technology delivery teams.

Essential Experience

We are looking for a proven OT / Industrial / Manufacturing Architect with experience operating in complex, highly regulated environments.

You should have:

• Strong experience designing OT / IT architectures within pharmaceutical, life sciences, chemical, food & beverage or similarly regulated manufacturing environments.
• Strong understanding of GxP / GMP regulated environments and the implications these have on technology architecture.
• Experience with IT/OT convergence and industrial control environments.
• Strong understanding of ISA-95 and/or Purdue-style architectures.
• Practical knowledge of industrial environments including PLC, DCS, SCADA, HMI, historians, MES and industrial networks.
• Experience with OT network architecture, segmentation, industrial DMZs and secure remote access.
• Strong understanding of integration technologies including OPC UA, APIs, middleware, event-driven architecture, ETL/ELT and historian integrations.
• Experience working with validated systems and understanding of Computerised System Validation (CSV) / Computer Software Assurance (CSA).
• Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+ / data integrity principles.
• Understanding of OT cybersecurity principles and frameworks, ideally including IEC 62443, NIST and/or ISO 27001.
• Ability to produce and communicate target-state architectures, reference architectures, roadmaps and architectural decision records.
• Excellent stakeholder management skills, with the ability to communicate effectively with engineering, automation, manufacturing, quality, cybersecurity and corporate IT.
• Experience operating in live manufacturing environments where changes must be carefully managed around production schedules, shutdowns, validation windows and batch campaigns.

Desirable

• TOGAF or equivalent Enterprise / Solution Architecture certification.
• ISA-95 / ISA-88 experience.
• IEC 62443 certification or equivalent OT cybersecurity experience.
• Experience with pharmaceutical MES / electronic batch record environments.
• Experience with LIMS, QMS, WMS, serialisation or laboratory systems.
• Experience with cloud and edge architectures within regulated manufacturing.
• Experience supporting major OT transformation, digital manufacturing or IT/OT convergence programmes.
• Previous experience working with global pharmaceutical manufacturing organisations.

Apply

If you are an experienced OT Architect, Industrial Architect, Manufacturing Architect or IT/OT Architect with a background in pharmaceutical or regulated manufacturing, we'd be keen to hear from you.

Please apply with your latest CV and we will be in touch to discuss the programme, rate and engagement in more detail.

GCS is acting as an Employment Business in relation to this vacancy.