Principal Architect - Pharmaceutical Manufacturing Technology

GCS Recruitment; United States; Hybrid; USD 180,000 - 250,000; Full time

Job summary

GCS Recruitment is seeking a Principal Architect to lead architecture across a regulated pharmaceutical manufacturing environment. You will shape strategy for manufacturing, labs, quality, automation, and enterprise platforms, ensuring GMP/data integrity and risk mitigation.

You will drive governance, enable IT/OT convergence, and mentor teams while aligning with validation and cybersecurity requirements in a highly visible leadership role.

Qualifications

• Significant experience in Enterprise Architecture, Solution Architecture, Manufacturing IT, OT Architecture, or senior technology leadership within regulated pharma/biotech environments.
• Strong understanding of pharmaceutical manufacturing technologies and processes.
• Proven ability to define roadmaps, governance frameworks, integration strategies, and platform lifecycle plans.
• Experience supporting GxP environments including validation, data integrity, change control, audit readiness.

Responsibilities

• Define and own the site technology architecture strategy, standards, roadmaps, and target-state architectures.
• Lead architecture governance across IT, OT, automation, manufacturing, laboratory, quality, and enterprise systems.
• Drive IT/OT convergence across ERP, MES, LIMS, QMS, WMS, SCADA, DCS, PLC, historians, and serialisation platforms.
• Guide digital manufacturing initiatives including MES, electronic batch records, lab digitisation, analytics, and cloud/edge tech.
• Ensure architecture decisions align with GMP, data integrity, cybersecurity, validation, and resilience.
• Develop architecture artefacts: capability maps, data flows, landscapes, integration diagrams, roadmaps, ADRs.
• Assess risk, compliance, cyber exposure, and lifecycle concerns; propose remediation strategies.
• Support investment decisions by evaluating value, risk, scalability, and TCO.
• Facilitate architecture review boards, risk assessments, and supplier design reviews.
• Mentor architects and engineers across the organisation.

Skills

Enterprise Architecture

Solution Architecture

Manufacturing IT

OT Architecture

Digital Manufacturing

Data integration

Cybersecurity

Regulatory compliance

Tools

ERP

MES

LIMS

QMS

SCADA

DCS

PLC

OPC UA

Job description

Role - Principal Architect - Pharmaceutical Manufacturing Technology

Duration - 6 months with very likely extension

Location - Hybrid / Remote

Shape the Future of Digital Manufacturing

We are seeking an experienced Principal Architect to provide architectural leadership across a complex pharmaceutical manufacturing environment. This role will define and govern technology strategy across manufacturing, laboratories, quality, engineering, warehouse operations, automation, infrastructure, data, cybersecurity, and enterprise platforms.

Working at the heart of a highly regulated GMP environment, you will ensure technology investments support operational excellence, product quality, regulatory compliance, patient safety, and long‑term digital transformation objectives.

This is a highly visible leadership role partnering with Site Leadership, Quality, Manufacturing, Engineering, Automation, Validation, Supply Chain, OT, and IT teams to shape the future technology landscape of a modern pharmaceutical manufacturing site.

What You'll Be Doing

• Define and own the site technology architecture strategy, standards, principles, roadmaps, and target‑state architectures.
• Lead architecture governance across IT, OT, automation, manufacturing, laboratory, quality, and enterprise systems.
• Drive IT/OT convergence and integration across platforms including ERP, MES, LIMS, QMS, WMS, EDMS, SCADA, DCS, PLC, historians, serialisation systems, CMMS, BMS, EMS, and manufacturing equipment.
• Guide digital manufacturing initiatives including MES, electronic batch records, paperless production, laboratory digitisation, analytics, AI, integration, cloud, and edge technologies.
• Ensure architecture decisions align with GMP, GxP, CSV/CSA, data integrity, cybersecurity, validation, and operational resilience requirements.
• Develop and maintain architecture artefacts including capability maps, data flows, system landscapes, integration diagrams, lifecycle roadmaps, and architecture decision records.
• Assess technical debt, obsolescence, compliance risks, cyber exposure, and platform lifecycle concerns, creating pragmatic remediation strategies.
• Support technology investment decisions through evaluation of business value, compliance impact, operational risk, scalability, maintainability, and total cost of ownership.
• Facilitate architecture review boards, design authorities, risk assessments, and supplier design reviews.
• Mentor architects, technical leads, automation engineers, and system owners across the organisation.

What We’re Looking For

• Significant experience in Enterprise Architecture, Solution Architecture, Manufacturing IT, OT Architecture, Digital Manufacturing, or senior technology leadership roles within pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environments.
• Strong understanding of pharmaceutical manufacturing technologies and processes.
• Proven experience defining architecture roadmaps, standards, governance frameworks, integration strategies, and platform lifecycle plans.
• Experience supporting GxP-regulated environments, including validation, data integrity, change control, audit readiness, and inspection support.
• Knowledge of manufacturing systems including:
  • ERP
  • MES
  • LIMS
  • ELN
  • QMS
  • WMS
  • eBR/eBMR
  • SCADA
  • DCS
  • PLC
  • Process Historians
  • Serialisation platforms
• Strong understanding of integration technologies, APIs, middleware, OPC UA, event‑driven architectures, master data management, and manufacturing data flows.
• Experience working with cross‑functional stakeholders including Manufacturing, Quality, Engineering, Automation, Validation, Supply Chain, Cybersecurity, and Infrastructure teams.

Desirable Experience

• TOGAF or equivalent architecture certification.
• Experience with ISA‑95, ISA‑88, IEC 62443, Purdue Model, NIST, ISO 27001, GAMP 5, CSA, or similar frameworks.
• Experience supporting large‑scale digital transformation, site expansion, manufacturing modernisation, OT remediation, or paperless manufacturing programmes.
• Exposure to cloud platforms, advanced analytics, AI, and Industry 4.0 initiatives within regulated environments.