Principal Architect - Digital Pharma Manufacturing

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

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.