Ilya Chyrko

Ilya Chyrko

Process Engineer

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  • Timeline

  • About me

    Senior Compliance Assurance Engineer – EPAM Systems

  • Education

    • Belarusian National Technical University

      2006 - 2011
      Bachelor's degree Micro and nanotechnology
  • Experience

    • ОАО "Интеграл"

      Jul 2011 - Aug 2013
      Process Engineer

      Modify process equipment particular to device packaging such as: wire bonders, welders, pick and place, digital measurement microscopes. measurement microscopes, soldering operations, electro-mechanical, chemical processing, etching (dry / wet), vacuum technology and associated process technologies. Substrate. Attach, Component placement, Epoxy dispense, hand & reflow furnace soldering, Resistance, Welding, Seam Sealing, vacuum processing, and wire-bonding used for Microelectronic Assembly.

    • ConvaTec

      Aug 2013 - Oct 2019
      Validation QE

      •Develop and execute timelines, validation plans, protocols, final reports, standard operating procedures, and other related documentation• Oversee protocol creation, implementation for validation related activities• Initiates, controls, and executes validations and procedures for engineering as required by FDA and ISO regulations related to the manufacturing of medical devices• Administer, direct, and guide the activities of technicians and engineers in validation work• Comply with GMP guidelines and good documentation practices• Train employees on validation requirements and procedures, as needed• Creates conceptual designs for fixtures, gages and special cutting tools as it relates to validations. Conducts tool design reviews with the Process Engineer, Tooling Team personnel, purchasing personnel, and outside tool suppliers as it relates to validations and process control• Supports activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with Corporate CAPA system• Resolves technical validation problems on assigned product lines in machining, metal finishing and assembly operations working with shop employees, process engineering, and quality personnel.• Works with Process Engineering and/or Quality Engineering on validation and technical manufacturing reviews of suppliers to support purchasing personnel certifying suppliers Show less

    • EPAM Systems

      Oct 2019 - now

      • Developed comprehensive documentation that meets organizational standards• Obtained a deep understanding of products and services and translated complex product information into simple, polished, and engaging content• Developed and maintained detailed databases of appropriate reference materials, including research, usability tests, and design specifications• Evaluated current content and develop innovative approaches for improvement• Researched, outlined, created, and edited new and existing content, working closely with various departments to understand project requirements• Gathered information from subject matter experts to develop, organize, and write procedure manuals, technical specifications, and process documentation• Identified all documentation repositories, revise and edit, and determine the best solution for data compilation and centralized storage Show less

      • Senior Compliance Assurance Engineer

        Oct 2019 - now
      • Senior Technical Writer

        Oct 2019 - Mar 2021
  • Licenses & Certifications

    • IoT Foundations: Fundamentals

      LinkedIn
      Mar 2020
      View certificate certificate
    • 21 CFR Part 820 Subpart G – Production and Process Controls

      Learnaboutgmp
    • Learning Confluence

      LinkedIn
      Nov 2019
      View certificate certificate
    • An introduction to process validation

      Learnaboutgmp
      Sept 2017
    • Medical Device Software - IEC62304

      Johner Institut GmbH
      Jan 2021
    • The release of medical devices to the EU market, connection with the New Medical Device Regulation MDR 745/2017 and requirements of ISO 13485:2016

      SGS
      Apr 2021
    • Six Sigma: Black Belt

      LinkedIn
      Mar 2020
      View certificate certificate
    • ISO 13485:2016

      Johner Institut GmbH
      Dec 2020
    • Lean Six Sigma Green Belt

      Oriel STAT A MATRIX
      Feb 2018
    • Project Management Foundations: Quality

      LinkedIn
      Mar 2020
      View certificate certificate