Historian Technical Architect - Assistant Manager / Deputy Manager - IT
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Description
<p class="MsoNormal"><b>Job Description: Historian Technical Architect (Pharma
Manufacturing)</b></p><p><b></b></p><b></b><p class="MsoNormal"><b>Role:</b> Historian Technical Architect – Pharmaceutical
Manufacturing<br />
<b>Experience:</b> 7-10 years total, with at least 6 years in process historian
architecture<br />
<b>Domain:</b> Pharma / Biotech / Life Sciences Manufacturing (GxP-regulated)<br />
<b>Employment Type:</b> Full-time</p><p></p><p class="MsoNormal"><b>Role Summary</b></p><p><b></b></p><b></b><p class="MsoNormal">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.</p><p></p><p class="MsoNormal"><b>Key Responsibilities</b></p><p><b></b></p><b></b><p class="MsoNormal"><b>Architecture and Design</b></p><p></p><ul style="margin-top:0cm;" type="disc">
<li class="MsoNormal">Define
the enterprise historian architecture, including site-level and
enterprise-level historians, tiered or federated topologies, high
availability, redundancy, and disaster recovery.<p></p></li>
<li class="MsoNormal">Design
data collection strategies from DCS, PLC, SCADA, and standalone equipment
using OPC DA/UA, interfaces, and connectors.<p></p></li>
<li class="MsoNormal">Build
asset hierarchies and data models, such as PI Asset Framework templates,
aligned with ISA-95 and ISA-88 batch structures.<p></p></li>
<li class="MsoNormal">Define
standards for tag naming, data compression and exception settings, event
frames, and batch context.<p></p></li>
<li class="MsoNormal">Architect
integrations with MES (e.g., Körber PAS-X, Emerson Syncade), LIMS, ERP
(SAP), QMS, and cloud or analytics platforms.<p></p></li>
</ul><p class="MsoNormal"><b>Implementation and Delivery</b></p><p></p><ul style="margin-top:0cm;" type="disc">
<li class="MsoNormal">Lead
historian deployments, upgrades, migrations, and site rollouts across
multiple manufacturing plants.<p></p></li>
<li class="MsoNormal">Configure
and optimize interfaces, buffering, collectives, AF, notifications, and
visualization tools (PI Vision, dashboards).<p></p></li>
<li class="MsoNormal">Guide
development teams and system integrators, and review designs,
configurations, and code.<p></p></li>
<li class="MsoNormal">Troubleshoot
performance, data loss, latency, and scalability issues.<p></p></li>
</ul><p class="MsoNormal"><b>GxP Compliance and Validation</b></p><p></p><ul style="margin-top:0cm;" type="disc">
<li class="MsoNormal">Ensure
solutions meet 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data
integrity principles.<p></p></li>
<li class="MsoNormal">Author
or review validation deliverables: URS, FS, DS, risk assessments,
IQ/OQ/PQ, and traceability matrices.<p></p></li>
<li class="MsoNormal">Support
CSV/CSA activities, change control, periodic reviews, and audit or
inspection readiness.<p></p></li>
<li class="MsoNormal">Define
audit trail, electronic record, access control, and backup/restore
strategies.<p></p></li>
</ul><p class="MsoNormal"><b>Data and Analytics Enablement</b></p><p></p><ul style="margin-top:0cm;" type="disc">
<li class="MsoNormal">Enable
use cases such as batch analytics, CPV (Continued Process Verification),
golden batch comparison, OEE, energy monitoring, and environmental
monitoring.<p></p></li>
<li class="MsoNormal">Architect
data pipelines from historian to data lakes and cloud platforms (Azure,
AWS, AVEVA CONNECT) for advanced analytics, AI/ML, and digital twin
initiatives.<p></p></li>
</ul><p class="MsoNormal"><b>Governance and Leadership</b></p><p></p><ul style="margin-top:0cm;" type="disc">
<li class="MsoNormal">Establish
historian standards, templates, and best practices for global deployment.<p></p></li>
<li class="MsoNormal">Collaborate
with OT/IT, Quality, Automation, Manufacturing, and Cybersecurity teams.<p></p></li>
<li class="MsoNormal">Align
OT architecture with network security (ISA/IEC 62443, Purdue model, DMZ
design).<p></p></li>
<li class="MsoNormal">Mentor
engineers and act as the technical point of contact with vendors and
stakeholders.<p></p></li>
</ul><p class="MsoNormal"><b>Required Skills and Experience</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc">
<li class="MsoNormal">Strong
hands-on expertise in at least one enterprise historian: <b>AVEVA PI
System (OSIsoft PI)</b> preferred; alternatives include AspenTech IP.21,
Honeywell PHD, AVEVA/Wonderware Historian, or GE Proficy Historian.<p></p></li>
<li class="MsoNormal">Deep
knowledge of PI Data Archive, PI AF, PI Interfaces/Connectors, PI Vision,
Event Frames, PI Integrators, and PI Web API.<p></p></li>
<li class="MsoNormal">Experience
integrating historians with DCS/PLC platforms such as Emerson DeltaV,
Siemens PCS 7/WinCC, Rockwell, and ABB.<p></p></li>
<li class="MsoNormal">Sound
understanding of OPC DA, OPC UA, MQTT, and industrial communication
protocols.<p></p></li>
<li class="MsoNormal">Working
knowledge of ISA-95, ISA-88, and batch manufacturing processes (API and/or
formulations, biologics a plus).<p></p></li>
<li class="MsoNormal">Proven
experience delivering validated systems in GxP environments.<p></p></li>
<li class="MsoNormal">Solid
grounding in Windows Server, SQL Server, virtualization, networking, and
OT cybersecurity.<p></p></li>
<li class="MsoNormal">Scripting
or development skills (PowerShell, Python, SQL, .NET, REST APIs) are an
advantage.<p></p></li>
</ul><p class="MsoNormal"><b>Preferred Qualifications</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc">
<li class="MsoNormal">Bachelor's
or Master's degree in Instrumentation, Electronics, Chemical, Computer
Engineering, or a related field.<p></p></li>
<li class="MsoNormal">AVEVA/OSIsoft
PI certifications.<p></p></li>
<li class="MsoNormal">Exposure
to cloud data platforms (Azure Data Lake, Databricks, Snowflake) and
Industry 4.0 or Pharma 4.0 programs.<p></p></li>
<li class="MsoNormal">Experience
with multi-site global rollouts and regulatory audits (USFDA, EMA, MHRA,
WHO-GMP).</li></ul><p>
</p><p class="MsoNormal"></p><p> </p>