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.
Industries Experience
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Experienced in Pharmaceutical (10.5 years) and Biotechnology (7 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Information Technology (13 years), Quality Assurance (13 years), Operations (4.5 years), Production (4 years), and Research and Development (2 years).
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
Profile
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