Historian Technical Architect - Assistant Manager / Deputy Manager - IT INFOTECH Corporate Office|Corp. Office, Ahmedabad, Gujarat, India 7 - 10 Years
Job Description
Job Description: Historian Technical Architect (PharmaManufacturing)
Role: Historian Technical Architect – PharmaceuticalManufacturing
Experience: 7-10 years total, with at least 6 years in process historianarchitecture
Domain: Pharma / Biotech / Life Sciences Manufacturing (GxP-regulated)
Employment Type: Full-time
Role Summary
We are looking for a Historian Technical Architect todesign, implement, and govern enterprise process data historian solutionsacross our pharmaceutical manufacturing sites. You will own the end-to-endarchitecture for collecting, contextualizing, storing, and serving time-seriesmanufacturing data from shop-floor systems to enterprise and analyticsplatforms. Every solution must stay compliant with GxP, 21 CFR Part 11, and EUAnnex 11.
Key Responsibilities
Architecture and Design
- Definethe enterprise historian architecture, including site-level andenterprise-level historians, tiered or federated topologies, highavailability, redundancy, and disaster recovery.
- Designdata collection strategies from DCS, PLC, SCADA, and standalone equipmentusing OPC DA/UA, interfaces, and connectors.
- Buildasset hierarchies and data models, such as PI Asset Framework templates,aligned with ISA-95 and ISA-88 batch structures.
- Definestandards for tag naming, data compression and exception settings, eventframes, and batch context.
- Architectintegrations with MES (e.g., Körber PAS-X, Emerson Syncade), LIMS, ERP(SAP), QMS, and cloud or analytics platforms.
Implementation and Delivery
- Leadhistorian deployments, upgrades, migrations, and site rollouts acrossmultiple manufacturing plants.
- Configureand optimize interfaces, buffering, collectives, AF, notifications, andvisualization tools (PI Vision, dashboards).
- Guidedevelopment teams and system integrators, and review designs,configurations, and code.
- Troubleshootperformance, data loss, latency, and scalability issues.
GxP Compliance and Validation
- Ensuresolutions meet 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ dataintegrity principles.
- Authoror review validation deliverables: URS, FS, DS, risk assessments,IQ/OQ/PQ, and traceability matrices.
- SupportCSV/CSA activities, change control, periodic reviews, and audit orinspection readiness.
- Defineaudit trail, electronic record, access control, and backup/restorestrategies.
Data and Analytics Enablement
- Enableuse cases such as batch analytics, CPV (Continued Process Verification),golden batch comparison, OEE, energy monitoring, and environmentalmonitoring.
- Architectdata pipelines from historian to data lakes and cloud platforms (Azure,AWS, AVEVA CONNECT) for advanced analytics, AI/ML, and digital twininitiatives.
Governance and Leadership
- Establishhistorian standards, templates, and best practices for global deployment.
- Collaboratewith OT/IT, Quality, Automation, Manufacturing, and Cybersecurity teams.
- AlignOT architecture with network security (ISA/IEC 62443, Purdue model, DMZdesign).
- Mentorengineers and act as the technical point of contact with vendors andstakeholders.
Required Skills and Experience
- Stronghands-on expertise in at least one enterprise historian: AVEVA PISystem (OSIsoft PI) preferred; alternatives include AspenTech IP.21,Honeywell PHD, AVEVA/Wonderware Historian, or GE Proficy Historian.
- Deepknowledge of PI Data Archive, PI AF, PI Interfaces/Connectors, PI Vision,Event Frames, PI Integrators, and PI Web API.
- Experienceintegrating historians with DCS/PLC platforms such as Emerson DeltaV,Siemens PCS 7/WinCC, Rockwell, and ABB.
- Soundunderstanding of OPC DA, OPC UA, MQTT, and industrial communicationprotocols.
- Workingknowledge of ISA-95, ISA-88, and batch manufacturing processes (API and/orformulations, biologics a plus).
- Provenexperience delivering validated systems in GxP environments.
- Solidgrounding in Windows Server, SQL Server, virtualization, networking, andOT cybersecurity.
Preferred Qualifications
- Bachelor'sor Master's degree in Instrumentation, Electronics, Chemical, ComputerEngineering, or a related field.
- AVEVA/OSIsoftPI certifications.
- Exposureto cloud data platforms (Azure Data Lake, Databricks, Snowflake) andIndustry 4.0 or Pharma 4.0 programs.
- Experiencewith 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
Location Corporate Office|Corp. Office, Ahmedabad, Gujarat, India
At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.
Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.