Ts. Kesavan Mutayah (B.Eng, P.Tech)

Experience

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  Top Glove

  Jun 2018 - Aug 2018

  Internship

  • Led a quality and process improvement initiative to significantly reduce pinholes from the coagulant side, ensuring improved product quality and production yield by 25%.• Successfully led a cost-saving project by implementing measures that substantially reduced chemical and latex consumption by 500L/month, contributing to enhanced operational efficiency.• Improved production line efficiency by implementing a streamlined labeling system for piping, facilitating a more organized and efficient workflow.• Conducted a comprehensive time study within the production rework team, identifying areas for improvement and implementing strategies to boost overall worker efficiency. Show less

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  Hovid Bhd

  Jan 2020 - Feb 2021

  Equipment Validation Engineer

  • Coordinated the equipment validation and qualification activities for a diverse range of pharmaceutical equipment (7 types of products) and critical utilities (HVAC, PWS, CAS) used in the manufacturing process.• Produced comprehensive documentation, including IQ/OQ/PQ validation protocols, reports, supplements, and addendums to ensure the registered equipment list for validation activities are systematic and organized.• Expertised in tableting machines, capsuling machines, coating machines and automation packing lines, showcasing a good understanding on the pharmaceutical machinery.• Conducted equipment process parameter improvements that led to a 15% increase in productivity by reducing the cycle time.• Conducted equipment failure analysis on production issues and implemented corrective actions to improve product quality.• Conducted root cause analysis and immediate remediation plan during production unplanned PM to reduce downtime.• Ensured the plant 5S and Safety are adhered to by conducting regular audits and providing feedback to employees.• Ensured that all the equipments SOP were updated, reviewed and established correctly.• Played a key role in temperature mapping and HVAC qualification processes, demonstrating proficiency in critical aspects of utilities functionality.• Conducted regular meetings, Kaizen and Gemba Walks to troubleshoot challenges and enhance operational efficiency. Show less

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  Teleflex

  Mar 2021 - Dec 2024

  Validation Engineer (Mold & Product)

  • Successfully led validation activities for 5 value streams by ensuring compliance with industrial standards.• Developed and executed comprehensive documentation, including validation protocols and reports, contributing to the seamless completion of projects.• Conducted feasibility and engineering studies for optimizing parameters in new molds and enhance production efficiency.• Implemented Reverse Engineering Studies (ES-RE) for old molds to ensure continuous improvement.• Played a pivotal role in Non-Conformance (NC), Risk Assessment (RA), CAPA and PFMEA processes to ensure product quality and regulatory compliance.• Liaised with suppliers, internal teams and stakeholders to ensure good parts delivery and project execution.• Performed the gap analysis between the current old molds & new molds.• Carried out supplier audit to ensure the mold conditions by reviewing supplier FAIR data, PM & 8D reports.• Actively participated in the DFX (design for excellence) team for Cost Improvement Projects (CIP’s), troubleshooting new mold issues, and prioritize critical projects to meet project deadlines.• Technical Proficiency : PVP, URS, FAT, SAT, IQ, OQ, PQ, Injection Molding Machine (IMM), final assembly processes, ISO standards and regulatory requirements, Biological Evaluation (BEV), and Sterility Assessment (SE), CAPA, Non-Conformance (NC), Risk Assessment (RA), Root Cause Analysis (RCA), PFMEA, Supplier collaboration, FAIR data review, and 8D reports.• Trainings : 7 QC Tools, 8 Steps Problem Solving, Project Management, Design and Manufacture of Plastic Parts, Root Cause Analysis (RCA), ISO 14971:2019 Risk Management & PFMEA for Medical Devices, MSA - GR&R, Communication & Interpersonal Skill, Process Validation, Minitab, Creative Thinking, Problem Solving and Decision Making, Troubleshooting for Injection Molding Machine by German-Malaysian Institute (GMi) Show less

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  ITL BioMedical

  Jan 2025 - now

  New Product Development Engineer

  • Manage product development projects, ensuring timely completion while overseeing Design History Files (DHF), tool testing, scheduling, and qualification of new materials, processes, and equipment.• Develop and validate robust test methods (TMV) for new products to ensure compliance with industry standards and regulations.• Support prototype fabrication for concept testing and collaborate with customer-facing teams to gather product feedback, provide samples, and arrange user testing.• Establish optimal process parameters and workflows, ensuring adherence to company SOPs, ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, TGA, and GMP requirements.• Work closely with process engineering, production, and QA/QC teams to develop manufacturing processes, inspection procedures, and documentation, including drawings, work instructions, and quality inspection plans.• Prepare and review DHF, Risk Management, and Usability Engineering Files to ensure full regulatory compliance, while conducting independent reviews of product documentation.• Trainings : ISO 14971-2019 Risk Management, Medical Device Requirements Engineering, Design Control for Medical Devices Show less