OT Architect - OutsideIR35

GCS Recruitment; United States; Remote; USD 95,000 - 129,000; Full time

Job summary

GCS Recruitment is partnering with a pharmaceutical manufacturing client to appoint an OT Architect for a 6-month Outside IR35 contract. The role is predominantly remote with one day per month on-site in the North Yorkshire region.

You will define target-state architecture, roadmaps and governance across IT, OT, automation, MES, SCADA and enterprise platforms, while ensuring GMP and data integrity compliance.

Qualifications

• Experience designing OT/IT architectures in regulated pharma/manufacturing.
• Familiarity with GMP/GxP and data integrity principles.
• Understanding of ISA-95 or Purdue-style architectures.
• Experience with OT networks, DMZs, and secure remote access.

Responsibilities

• Define OT/site architecture vision, standards and roadmaps.
• Provide leadership across OT, automation, MES, SCADA, DCS, PLCs, historians, and enterprise platforms.
• Govern IT/OT convergence and cross-domain integration architectures.
• Develop target-state architectures and pragmatic transition roadmaps.
• Work with MES, LIMS, QMS, WMS, ERP, EDMS, serialization, CMMS, EBRs and shop-floor systems.
• Define secure architectures covering industrial networks, segmentation and disaster recovery.
• Assess OT environments for technical debt, cyber risk and resilience gaps.
• Develop architecture patterns for validated systems including CSV/CSA traces and data integrity controls.
• Ensure architectures support GMP, data integrity and patient safety.
• Collaborate with Engineering, Manufacturing, Quality and Cybersecurity teams.
• Support CSV/CSA, validation, risk assessments and design reviews.
• Lead architecture workshops and design authorities.

Skills

OT architecture

GxP

ISA-95

OPC UA

Cybersecurity

IT/OT convergence

DCS/SCADA

Tools

MES

LIMS

WMS

QMS

ERP

EDMS

CMMS

HMI

PLC

Job description

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.