Historian & IT-OT Functional Manager (Manufacturing Function – IT)

Zydus Group; Ahmedabad District; Sur place; INR 4 000 000 - 7 000 000; Plein temps

Résumé du poste

Zydus Group is seeking an experienced Historian & IT-OT Functional Manager for the Manufacturing Function. The role requires deep knowledge of historians, MES/LIMS/ERP integration, and a track record in pharma operations, with hands-on leadership across sites.

The candidate will own functional design from requirements to go-live, collaborate with architects and system integrators, ensure 21 CFR Part 11/GAMP 5 compliance, and drive adoption of IT-OT solutions that deliver measurable business

Qualifications

• Experience in pharma manufacturing IT/OT and historian deployments.
• Ability to translate manufacturing needs into IT/OT requirements.
• Knowledge of validation and GxP compliance.
• Experience with multi-site rollouts preferred.

Responsabilités

• Act as Manufacturing IT point of contact across plant and corporate teams.
• Translate business needs into functional requirements and specifications.
• Own the functional design of historian solutions across sites and lead implementation.
• Define data flows and integration with MES, LIMS, ERP, QMS and CMMS.
• Lead UAT, cutover planning, and hypercare support after go-live.
• Drive change management, training, and adoption to realize business value.

Connaissances

AVEVA PI System

Process Historian

DCS/SCADA/PLC

MES/LIMS/SAP

ISA-95/ISA-88

Jira/Azure DevOps/HP ALM

BPMN/Visio

GxP Validation

Data Analysis

Formation

B.Pharm / M.Pharm

B.E / B.Tech / M.E / M.Tech

Engineering disciplines

Outils

Jira

Azure DevOps

HP ALM

Description du poste

Job Description:

Role: Historian & IT-OT Functional Manager (Manufacturing Function – IT)

Designation: Manager

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:

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. The individual 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. Also, will understand how the plant runs, translate manufacturing and quality needs into clear IT and OT requirements, and lead implementation through to adoption and measurable business value.

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.
• Track and report business benefits and value realization, such as reduced investigation time, improved OEE, and reduced manual data collection.

8. Operations and Continuous Improvement

• Act as the functional escalation point for historian and IT-OT application issues.
• Work with support teams on incident, problem, and change management, and help define business‑aligned SLAs.
• Periodically review system usage and data quality with site teams.
• Standardize solutions and templates across sites to support faster, consistent rollouts.

9. Team and Vendor Leadership

• Lead and mentor functional analysts and business analysts within the manufacturing IT team.
• Manage system integrators and vendors on functional scope, quality, and timelines.
• Coordinate with global and site IT, OT, automation, cybersecurity, and quality teams.

Required Manufacturing Knowledge

The candidate must have solid, practical understanding of:

• Pharma manufacturing types: API (chemical synthesis), oral solid dosage (OSD), sterile/injectables, and/or biologics.
• Unit operations and equipment, for example dispensing, granulation (RMG, FBD), blending, compression, coating, capsule filling, packaging, reactors, centrifuges, dryers, distillation, filtration, fermentation, chromatography, lyophilization, and aseptic filling, depending on site type.
• Batch lifecycle: process order, recipe, BMR/BPR and eBR, in-process controls, equipment cleaning and status logs, yield reconciliation, batch record review, and batch release.
• Plant utilities and environment: HVAC, cleanroom classification, WFI/PW systems, clean steam, compressed air, and environmental monitoring.
• Quality processes: deviations, CAPA, change control, OOS/OOT, APQR, and CPV.
• Maintenance and engineering processes: calibration, preventive maintenance, equipment qualification, and breakdown management.
• Manufacturing KPIs: OEE, yield, cycle time, right-first-time, downtime, and batch throughput.

Required Technical and Functional Skills

• Strong functional knowledge of process historians, preferably AVEVA PI System (PI AF, Event Frames, PI Vision).
• Working understanding of automation systems (DCS, PLC, SCADA) such as Emerson DeltaV, Siemens PCS 7/WinCC, Rockwell, or ABB.
• Functional understanding of MES (Körber PAS-X, Emerson Syncade, Siemens Opcenter), LIMS (LabWare, LabVantage, Empower), SAP (PP-PI, QM, PM, MM), and QMS platforms (e.g., TrackWise, Veeva QMS).
• Knowledge of ISA-95, ISA-88, and basic integration concepts (OPC UA/DA, interfaces, APIs, data flows).
• Strong business analysis skills: process mapping (BPMN/Visio), requirement elicitation, fit-gap analysis, user stories, and UAT management.
• Hands-on experience delivering and validating GxP computerized systems.
• Familiarity with project delivery methodologies (Waterfall, Agile, hybrid) and tools such as Jira, Azure DevOps, or HP ALM.
• Basic data skills (Excel, SQL, Power BI or similar) to analyze and validate manufacturing data.

Preferred Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemical Engineering, Instrumentation, or Mechanical/Electrical Engineering; an MBA or IT qualification is a plus.
• Prior experience working in a plant role (production, engineering, automation, or QA) before moving into IT is highly valued.
• Certifications such as AVEVA/OSIsoft PI, CBAP/PMI-PBA, PMP/PRINCE2, ITIL, Six Sigma, or Lean.
• Experience with multi-site or global rollouts and Pharma 4.0 or digital manufacturing programs.