Kaliyan Muthukrishnan
Techno-Functional Consultant – Digital Lab & Manufacturing Systems
Experience
Techno-Functional Consultant – Digital Lab & Manufacturing Systems
Dynavax Technologies
- Led SampleManager LIMS 21.x & LabWare LIMS v8 implementation, reducing manual lab errors by 40% and improving data traceability.
- Configured LW LIMS & SM LIMS 21.2: workflow design, role-based access control (RBAC), and master data management.
- Designed and configured LES workflows: sample lifecycle management, test assignments, approvals, and result review processes.
- Managed Master Menu and CI configuration, ensuring consistency, data integrity, and regulatory compliance.
- Integrated LIMS 21.2 with MES, ERP, EM, WinKQCL (Lonza MODA), SoftMax Pro, Empower, and Chromeleon CDS via REST APIs and web services.
- Implemented PAS-X MES: architecture design, multi-platform implementation (PAS-X, Siemens Opcenter), and integration with PLC, SCADA, and DCS systems.
- Executed IQ/OQ/PQ qualification protocols and Validation Summary Reports (VSR) for QC analytical and utility systems in aseptic and sterile production environments.
- Developed and reviewed Risk Assessments, Traceability Matrices, and Data Integrity evaluations in accordance with ALCOA+, 21 CFR Part 11, and EU Annex 11.
- Led EMA/FDA/WHO inspection readiness, standardized CQV SOPs, enabled digital CQV integration (LIMS/CDS/MES/SCADA/ERP/SDMS), and ensured 21 CFR Part 11 & Annex 11 compliance.
- Managed secure OT cybersecurity: network configuration and access control.
- Configured NuGenesis SDMS for document/data management, CDS/LIMS integration, workflow automation, and reporting.
CSV & Lab Automation Specialist
QIAGEN
- Led validation, qualification, calibration, and engineering activities for GxP applications (LIMS, MES, ERP, QMS) and new lab equipment.
- Prepared and executed VMP, RA, URS, FRS, DS/CS, DQ, IQ, OQ, PQ, TM, and VSR for GxP systems.
- Executed risk-based validation (GAMP 5) and ALCOA+ compliance.
- Managed Computer Systems Validation across platforms including SAP, Veeva, and MES.
- Deployed R&D systems: ELN, LIMS, eDMS, LMS, RIM, eCTD, eTMF, CTMS, Pinnacle 21, and SAS.
- Configured AVEVA OSI PI: server, AF/Archive management, real-time data collection, AF hierarchy, event frames, and PI Vision.
- Designed and implemented interfaces: LIMS ↔ MES, MES ↔ ERP, L2 ↔ MES/L3 via OSI PI and RESTful APIs.
- Ensured compliance with ISA-088 & 095, GAMP 5 – 2nd Edition, 21 CFR Part 11 & 820, and ALCOA+.
- Used supporting tools: TrackWise, ServiceNow, JIRA, Kneat, MasterControl, and Veeva Docs.
CSV & Lab Informatics Analyst
Cognizant
- Led LabWare & LabVantage LIMS data migration, reducing transition errors by 35% and ensuring compliance on AWS & Azure.
- Configured and supported PAS-X MES 3.x for batch production and electronic batch records (EBR).
- Designed and implemented Master Batch Records (MBR) and production workflows for compliant, paperless manufacturing.
- Supported EBR execution and batch lifecycle management, including exception handling, deviations, and review by exception (RBE).
- Modeled equipment, resources, and process parameters aligned with ISA-95 standards.
- Integrated PAS-X with LIMS, ERP, and shop-floor equipment for seamless data flow.
- Enhanced master data, equipment models, exception handling, and GMP/21 CFR Part 11 workflows.
- Technologies: LIMS/ELN, SAP QM, MES, SQL, Agile/SCRUM, ISO 27001 ISMS.
Lab Automation Consultant
HCL Technologies
- Configured and supported Empower 3.x/Chromeleon CDS: method & sequence management, instrument integration, result processing, and system customization.
- Implemented NuGenesis SDMS for scientific data management, CDS/LIMS integration, workflow automation, and reporting.
- Led MODA Environmental Monitoring configuration: workflows, alerts, sensor/location mapping, limits & excursions management, and GMP-compliant upgrades.
- Configured and maintained AVEVA OSIsoft PI: PI Server, AF, Archive, real-time data collection, AF hierarchy, event frames, PI Vision dashboards, and security.
- Ensured GAMP 5, 21 CFR Part 11, and ALCOA+ compliance, supporting audits and validated system lifecycles.
- Implemented SAP & PAS-X interface using IDoc transactions.
- Executed full CQV lifecycle (IQ/OQ/PQ, RA, TM, VSR) for QC analytical and utility systems per GAMP 5 and Annex 15.
Summary
Lab Automation specialist GxP Lab Automation | CSV | Digital Transformation inPharma and Biotech. With 14+ years of expertise in GxP Lab Automation, CSV, and Digital Transformation, I help pharmaceutical and biotech companies optimize lab and manufacturing operations, accelerate compliance, and integrate cutting-edge AI/Cloud solutions for next-gen therapeutics.
Skills
Techno-functional Consultant – Digital Lab & Manufacturing Systems
Samplemanager Lims 21.x Configuration – Les Configuration, Workflow Setup, Master Menu & Ci Updates, Master Data Management, User Security, System Configuration, Customization, Upgrades
Pas-x Mes 3.x Configuration – Mbr Design/configuration, Ebr Execution, Batch Lifecycle, Equipment And Resource Modeling, Mes–lims And Mes–sap Integration, User Security
Labware Lims 7.x Configuration – Workflows, Tests, Samples, Instruments, Specifications, Products, Methods, Stability, Users, Roles, Permissions, Erp/mes Integration, Compliance And Audit Trails
Empower 3.x / Chromeleon Configuration – Method And Sequence Management, Instrument Integration, Result Processing, User Roles, System Customization
Nugenesis Sdms Configuration – Document/data Management, Cds/lims Integration, Access Control, Workflow Automation, Reporting
Moda Em Configuration – System Configuration, Em Workflows And Alert Setup, Location/sensor Mapping, Limits And Excursions Management, User Roles/security, Data Integrity, Reporting, Gmp-compliant System Customization And Upgrades
Aveva Osi Pi Configuration – Pi Server/af/archive Management, Real-time Data Collection, Af Hierarchy And Event Frames, Pi Vision Dashboards, Reporting, Security
Interface And Integration Configuration – Lims ↔ Mes, Mes ↔ Erp, L2 ↔ Mes/l3 Via Osi Pi, Restful Apis, Data Mapping, Automated Workflows, Gxp-compliant Interfaces
Regularity Standard Expertise – Isa-088 And Isa-095, Gamp 5 – 2nd Edition, 21 Cfr Part 11, 21 Cfr Part 820, Alcoa+ Data Integrity Principle
Supporting Tool Usage – Trackwise, Servicenow, Jira, Kneat, Mastercontrol, Veeva Docs
Computer Language Expertise – Python, Sql, C#/.net, Java
Csv – It Systems: Lims, Mes, Cds, Eln, Sdms, Stms | Urs, Frs/fds, Risk Assessment, Traceability, Iq/oq/pq, Test Protocols, Interface Validation, Data Integrity, Security, Documentation And Change Control
Cqv – Lab/process Equipment: Hplc, Gc, Lc-ms, Spectrophotometers, Balances, Pipettes, Liquid Handlers, Ph/conductivity Meters, Bioreactors, Fermenters, Autoclaves, Mixers, Commissioning, Iq/oq/pq, Functional Testing, Calibration, Risk Assessment, Sop Compliance, Preventive Maintenance
Lims/eln, Sap Qm, Mes, Sql, Agile/scrum, Iso 27001 Isms, Digital Transformation And System Efficiency
Languages
Education
Anna University
Master of Biotechnology · Biotechnology · Chennai, India
Anna University
Bachelor of Pharmaceutical Engineering · Pharmaceutical Engineering · Chennai, India
Certifications & licenses
AWS Certified Cloud Practitioner
Empower 3 FR2 Administrator
Introduction to Generative Adversarial Networks (GANs)
LabWare LIMS V7.0 Administrator
Waters HPLC Validation Administrator
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