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).

Job Snapshot

Updated Date

24-09-2026

Job ID

JOB11142

Division

INFOTECH

Location

Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

Experience

7 - 10 Years

Employee Type

P-P8-Probationer-HO Executive

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