KMAbout Kaliyan
15 years of experience in GxP Lab Automation, CSV, and regulatory
compliance in pharmaceutical and biotechnology industries. Proven
technical, functional, and quality expertise in LIMS, ELN, CDS, SDMS, ERP,
and integration with MES/ERP/QMS platforms. Experienced as an
integration technology architect, designing and implementing QC lab app
integrations with manufacturing applications such as MES and ERP. Adept
at ensuring compliance (GAMP 5, 21 CFR Part 11, EU Annex 11) while
optimizing lab workflows and enhancing operational efficiency. Additionally,
expertise in advanced drug discovery platforms powered by GAN, VAE, and
GNN models accelerates next-generation biologicals. Also worked on
the rollout of clinical applications like the Veeva suite, including eTMF and
CTMS. Skilled in cloud-based solutions (AWS), automation, and digital
transformation for biopharma and life sciences industries.
English
Native or bilingual
German
Fluent
Can work on-site
Düsseldorf (up to 50km)
Experience
- Dynavax GmbHSenior GxP Specialist (Lab Automation)PHARMACEUTICALS INDUSTRYJuly 2021 - Today (4 years and 11 months)GermanyLed Thermo Fisher SampleManager LIMS 21.1 implementation, reducing manual lab errors by 40% and improving data traceability.Managed AWS-based cloud infrastructure with 99.9% uptime, ensuring full GxP and GMP compliance.Integrated MODA-EM and FDC systems for real-time environmental monitoring compliant with FDA and EMA regulations.Accelerated CSV lifecycle using GAMP 5 principles, improving audit readiness and cutting validation time.Oversaw rollout of LabSolutions CDS, spectrophotometer systems, and Microsoft D365 (SCM, inventory, quality, manufacturing).Developed automation workflows and analytics using SAS and Python, optimizing MS&T and QC lab performance.Defined IT/OT segregation frameworks aligned with GAMP 1–5, driving digital transformation and data integrity.Served as ServiceNow SME, managing GxP change control, CAPA, and compliance activities across the lab ecosystem.
- QIAGEN GmbHGxP Lab Apps & CSV ConsultantBIOTECHMay 2019 - July 2021 (2 years and 2 months)GermanyResponsible for all Validation, Qualification, Calibration, and Engineering activities of the project.Preparation, Execution, and training of Site QA, Validation, Engineering and Productiondepartment personnel for URS, DQ, IQ, OQ, and PQ of New equipment / InstrumentPreparation, Review, Training, and execution of all engineering-related SOP’s and Documentation of the Engineering Department according to EU, MHRA, and FDA requirements.Performing Impact assessment for identification of Qualification and validation requirements of Equipment, Instruments & amp; utilitiesPreparation/review of master validation plan in regard to facility, equipment, process, cleaning, and utilitiesIdentification, coordination, and execution of validation and Qualification needs as per cGMP, Regulatory and VMP requirements.Co-ordination with engineering and projects department for preparation and review of new and existing project plans, drawings and layouts.Performing Quality Risk Assessment of Equipment, Utilities, Instruments, Facility, and Process according to ICH Q9 guidelines• Computer Systems Validation & Qualification (Software/Instrument/Equipment/Interface)• Various System including, SAP PP-QM, MM, EHS and PIPO, Salesforce CRM, Veeva Quality Docs, Veeva Submission, Veeva eTMF, MES, MasterControl and Trackwise• SampleManager LIMS, ELN, LES-IM, and Clinical Safety System and Other ERPs System• Quality Management Systems (QMS)• SDLC (Waterfall; V-model; Agile; Risk-Based Rapid Development)• cGxP (GLP/GCP/GMP), Good Documentation Practice (GDP)• GAMP Guidelines applicable to CSV• 21 CFR Part 11 Electronic Records; Electronic Signatures• EU Annex 11 Computerized Systems• ISO/IEC/IEEE Software Testing Standards• Medical Devices (ISO 13485)• IEC 62304 Medical Device Software Life Cycle• ISO 14971 Medical Device Risk Management• FDA 21 CFR 820 Quality System Regulation• Quality Systems Audit & Support
- Cognizant TechnologyGxP Lab Automation SpecialistPHARMACEUTICALS INDUSTRYMarch 2015 - May 2019 (4 years and 2 months)HungaryLIMS & GxP Data Migration: Led seamless LIMS migration, cuttingtransition errors by 35%. Executed GxP data migration to AWS & Azure,ensuring compliance.R&D Systems Deployment: Implemented ELN, LIMS, eDMS, LMS,RIM, eCTD, eTMF, CTMS, Pinnacle 21, and SAS, streamlining research& regulatory workflows.Regulatory & Quality Compliance: Enforced GxP validation, ISO27001/9001, and GAMP 5, ensuring FDA/EMA compliance and auditreadiness.Data Governance & Risk Management: Built robust data governanceframeworks, enhancing compliance, reporting accuracy, and riskmitigation.Tech & IT Mastery: Expert in LIMS/ELN, SAP QM, MES, SQL,Agile/SCRUM, and ISO 27001 ISMS, driving system efficiency and digitaltransformation.Validation & Lifecycle Oversight: Spearheaded validation (DQ, IQ, OQ,PQ), risk analysis, and lifecycle management for critical lab &manufacturing systems.
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Education
- SampleManager LIMS 21.1 Administration LabWare LIMS V7.0 Administrator – 01 AWS Certified Cloud Practitioner Empower 3 FR2 Administrator Waters HPLC Validation Administrator CSV GAMP Professional Introduction to Generative Adversarial Networks (GANs) Introduction to Large Language ModelsSampleManager LIMS 21.1 Administration LabWare LIMS V7.0 Administrator – 01 AWS Certified Cloud Practitioner Empower 3 FR2 Administrator Waters HPLC Validation Administrator CSV GAMP Professional Introduction to Generative Adversarial Networks (GANs) Introduction to Large Language Models
- Master of BiotechnologyAnna UniversityMaster of Biotechnology