Historian & IT-OT Functional Lead - Manager - IT

Job Description: Historian & IT-OT Functional Manager
(Manufacturing Function – IT)
Role: Historian & IT-OT Functional Manager /
Manufacturing Function Lead
Team: IT (Digital Manufacturing / Manufacturing IT)
Experience: 12–18 years total, with at least 6 years in pharmaceutical
manufacturing operations or manufacturing IT/OT, and at least 4 years in a
functional lead or manager role
Education: B. Pharm, M. Pharm/ B. E, M.E / B. Tech, M.Tech - Chemical,
Instrumentation, Mechanical, Electrical Engineering, Information Technology, or
related disciplines.
Location: Ahmedabad (The position follows plant
operating schedules and a 6-day working week.
Role Summary
We are looking for a Historian & IT-OT Functional
Manager who will serve as the voice of manufacturing within the IT
organization. The role is the bridge between plant operations and
technology: you will understand how the plant actually runs, translate
manufacturing and quality needs into clear IT and OT requirements, and lead
implementation through to adoption and measurable business value.
The ideal candidate has worked in or closely with pharma
manufacturing, understands unit operations, batch lifecycle, equipment, and
shop-floor workflows, and also understands how historians, automation, MES,
LIMS, and ERP integrate. You will own the functional side of historian and
IT-OT solutions from requirement to go-live and beyond, working with
architects, developers, system integrators, and site teams.
Key Responsibilities
1. Manufacturing Business Partnering
Act
as the primary IT point of contact for Manufacturing, Engineering, Quality
Assurance, Quality Control, Maintenance, Warehouse, and Supply Chain teams
at plant and corporate levels.
Understand
plant priorities such as throughput, yield, right-first-time, batch cycle
time, deviation reduction, compliance, and cost, and align IT-OT
initiatives to them.
Spend
regular time on the shop floor to observe processes, identify pain points,
and uncover digital opportunities.
Build
trusted relationships with plant heads, production managers, QA heads, and
engineering leads.
Maintain
a prioritized demand backlog and business-aligned roadmap for historian
and IT-OT solutions.
2. Business-to-IT Requirement Translation
Lead
requirement workshops with manufacturing and quality stakeholders to
capture business needs, current-state (as-is) processes, and desired
future state (to-be).
Map
manufacturing processes end to end, for example process order release,
material dispensing, batch execution, in-process checks, equipment
cleaning and status, batch record review, and batch release.
Translate
business needs into structured deliverables: business requirements,
User Requirement Specifications (URS), functional specifications (FS), use
cases, user stories, process flows, data mapping, and acceptance criteria.
Conduct
fit-gap analysis against standard product capabilities and recommend
configuration over customization wherever possible.
Define
which process parameters, alarms, events, and batch context need to be
captured, contextualized, and reported, and why they matter to the
business.
Clearly
explain technical constraints, options, and trade-offs back to business
users in plain language.
3. Historian Functional Ownership
Own
the functional design of the process historian (e.g., AVEVA PI System,
AspenTech IP.21, Honeywell PHD, Proficy) across sites.
Define
with process and engineering teams which tags, critical process parameters
(CPPs), critical quality attributes (CQAs), and utilities data must be
collected.
Drive
the design of asset hierarchies, templates, batch and event frames, and
calculations based on actual equipment and process structure (ISA-88 /
ISA-95).
Specify
dashboards, trends, reports, and alerts for production, QA, engineering,
and management users.
Enable
business use cases such as:
Batch
trending and golden batch comparison
Continued
Process Verification (CPV) and Annual Product Quality Review (APQR) data
support
Deviation
and investigation support with process data
OEE,
downtime, and equipment performance
Environmental
monitoring (HVAC, cleanrooms, differential pressure, temperature,
humidity)
Utilities
and energy monitoring (WFI, purified water, steam, compressed air, HVAC)
Cold
chain and storage condition monitoring
4. IT-OT Integration Functional Leadership
Define
functional requirements for integration between shop-floor systems (DCS,
PLC, SCADA, BMS, EMS, standalone equipment) and enterprise systems (MES,
LIMS, ERP/SAP, QMS, CMMS, WMS).
Specify
business data flows, for example process order download from SAP to MES,
material consumption and goods movement back to ERP, equipment status to
MES, process data to eBR, and results from LIMS to batch release.
Work
with the IT-OT Integration Architect and Historian Architect to confirm
that technical designs meet business needs.
Ensure
consistent master data and naming across equipment, materials, recipes,
and sites.
Support
Pharma 4.0 initiatives including analytics, AI/ML use cases, digital
twins, and predictive maintenance by clearly defining business context and
data needs.
5. Implementation and Delivery Ownership
Lead
the functional workstream of historian and IT-OT projects from initiation
through design, build, testing, deployment, and hypercare.
Plan
functional activities, milestones, resources, and dependencies in
coordination with project managers, architects, and system integrators.
Guide
developers and integrators on business logic, configuration, and process
understanding.
Lead
User Acceptance Testing (UAT): prepare test scenarios with business
users, coordinate execution, and track defects to closure.
Prepare
cutover and go-live plans with site teams, carefully planning around
production schedules, campaigns, and shutdowns.
Provide
hypercare support after go-live and ensure smooth handover to support
teams.
Manage
scope changes through a structured change request process.
6. GxP Compliance, Validation and Data Integrity
Ensure
all solutions meet 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+
requirements.
Author
or own functional validation documents: URS, FS, functional risk
assessments, requirements traceability matrix, UAT/PQ protocols, and
validation summary inputs.
Work
closely with QA and CSV teams on validation strategy, including CSA
risk-based approaches.
Ensure
changes follow site change control, impact assessment, and periodic review
processes.
Represent
historian and IT-OT systems during regulatory inspections and audits
(USFDA, EMA, MHRA, WHO-GMP, and local authorities), explaining business
use and data flows.
7. Change Management, Training and Adoption
Drive
user adoption through training programs, SOP updates, work instructions,
and user guides.
Identify
and develop super-users and site champions.
Collect
user feedback after go-live and drive continuous improvements.

Employment type
P-P8-Probationer-HO Executive

Work arrangement
No