Historian Technical Architect

Job Description: Historian Technical Architect (Pharma
Manufacturing)
Role: Historian Technical Architect – Pharmaceutical
Manufacturing
Experience: 7-10 years total, with at least 6 years in process historian
architecture
Domain: Pharma / Biotech / Life Sciences Manufacturing (GxP-regulated)
Employment Type: Full-time
Role Summary
We are looking for a Historian Technical Architect to
design, implement, and govern enterprise process data historian solutions
across our pharmaceutical manufacturing sites. You will own the end-to-end
architecture for collecting, contextualizing, storing, and serving time-series
manufacturing data from shop-floor systems to enterprise and analytics
platforms. Every solution must stay compliant with GxP, 21 CFR Part 11, and EU
Annex 11.
Key Responsibilities
Architecture and Design
Define
the enterprise historian architecture, including site-level and
enterprise-level historians, tiered or federated topologies, high
availability, redundancy, and disaster recovery.
Design
data collection strategies from DCS, PLC, SCADA, and standalone equipment
using OPC DA/UA, interfaces, and connectors.
Build
asset hierarchies and data models, such as PI Asset Framework templates,
aligned with ISA-95 and ISA-88 batch structures.
Define
standards for tag naming, data compression and exception settings, event
frames, and batch context.
Architect
integrations with MES (e.g., Körber PAS-X, Emerson Syncade), LIMS, ERP
(SAP), QMS, and cloud or analytics platforms.
Implementation and Delivery
Lead
historian deployments, upgrades, migrations, and site rollouts across
multiple manufacturing plants.
Configure
and optimize interfaces, buffering, collectives, AF, notifications, and
visualization tools (PI Vision, dashboards).
Guide
development teams and system integrators, and review designs,
configurations, and code.
Troubleshoot
performance, data loss, latency, and scalability issues.
GxP Compliance and Validation
Ensure
solutions meet 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data
integrity principles.
Author
or review validation deliverables: URS, FS, DS, risk assessments,
IQ/OQ/PQ, and traceability matrices.
Support
CSV/CSA activities, change control, periodic reviews, and audit or
inspection readiness.
Define
audit trail, electronic record, access control, and backup/restore
strategies.
Data and Analytics Enablement
Enable
use cases such as batch analytics, CPV (Continued Process Verification),
golden batch comparison, OEE, energy monitoring, and environmental
monitoring.
Architect
data pipelines from historian to data lakes and cloud platforms (Azure,
AWS, AVEVA CONNECT) for advanced analytics, AI/ML, and digital twin
initiatives.
Governance and Leadership
Establish
historian standards, templates, and best practices for global deployment.
Collaborate
with OT/IT, Quality, Automation, Manufacturing, and Cybersecurity teams.
Align
OT architecture with network security (ISA/IEC 62443, Purdue model, DMZ
design).
Mentor
engineers and act as the technical point of contact with vendors and
stakeholders.
Required Skills and Experience
Strong
hands-on expertise in at least one enterprise historian: AVEVA PI
System (OSIsoft PI) preferred; alternatives include AspenTech IP.21,
Honeywell PHD, AVEVA/Wonderware Historian, or GE Proficy Historian.
Deep
knowledge of PI Data Archive, PI AF, PI Interfaces/Connectors, PI Vision,
Event Frames, PI Integrators, and PI Web API.
Experience
integrating historians with DCS/PLC platforms such as Emerson DeltaV,
Siemens PCS 7/WinCC, Rockwell, and ABB.
Sound
understanding of OPC DA, OPC UA, MQTT, and industrial communication
protocols.
Working
knowledge of ISA-95, ISA-88, and batch manufacturing processes (API and/or
formulations, biologics a plus).
Proven
experience delivering validated systems in GxP environments.
Solid
grounding in Windows Server, SQL Server, virtualization, networking, and
OT cybersecurity.
Scripting
or development skills (PowerShell, Python, SQL, .NET, REST APIs) are an
advantage.
Preferred Qualifications
Bachelor's
or Master's degree in Instrumentation, Electronics, Chemical, Computer
Engineering, or a related field.
AVEVA/OSIsoft
PI certifications.
Exposure
to cloud data platforms (Azure Data Lake, Databricks, Snowflake) and
Industry 4.0 or Pharma 4.0 programs.
Experience
with multi-site global rollouts and regulatory audits (USFDA, EMA, MHRA,
WHO-GMP).

Experience
7 - 10 Years

Employment type
P-P8-Probationer-HO Executive

Work arrangement
No