Dr. Denys Bilko

Dr. Denys Bilko Email and Phone Number

Expert in Clean Room & Laboratory Planning | GMP Compliance Specialist | Biosafety & Laboratory Quality Management Consultant @ International school of technical legislation and quality management
Dr. Denys Bilko's Location
Bad Ditzenbach, Baden-Württemberg, Germany, Germany
About Dr. Denys Bilko

As a seasoned expert in clean room and laboratory planning, I bring over two decades of specialized experience in designing, planning, and implementing state-of-the-art facilities that meet stringent regulatory standards. My work spans across GMP-compliant clean rooms, biosafety level 2 and 3 laboratories, and advanced healthcare facilities, ensuring optimal performance, safety, and compliance.I excel in delivering tailored solutions that integrate architectural innovation with cutting-edge technology, enhancing operational efficiency and regulatory compliance for my clients. My international project management experience, coupled with deep expertise in risk analysis, quality management, and biosafety, enables me to lead complex projects from concept to completion, ensuring that each facility meets the highest standards of excellence.My commitment to continuous improvement and adherence to best practices in clean room validation and laboratory quality management has made me a trusted advisor and consultant for clients globally. Whether you are looking to design a new facility, optimize existing operations, or navigate complex regulatory landscapes, I provide the strategic insight and technical expertise necessary to achieve your goals.

Dr. Denys Bilko's Current Company Details
International school of technical legislation and quality management

International School Of Technical Legislation And Quality Management

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Expert in Clean Room & Laboratory Planning | GMP Compliance Specialist | Biosafety & Laboratory Quality Management Consultant
Employees:
1
Dr. Denys Bilko Work Experience Details
  • U2Projektagentur
    Expert Level Clean Room Project Consultant
    U2Projektagentur Apr 2024 - Present
    Ulm, Baden-Württemberg, Germany
  • Technology Project Group
    Director And Founder
    Technology Project Group Aug 2021 - Present
    Kyiv, Kyiv City, Ukraine
    🔹 Directed the design and planning of healthcare and laboratory facilities, including biosafety level 2 and 3 laboratories, ensuring compliance with international standards.🔹 Integrated advanced technologies with architectural designs, enhancing the functionality, safety, and efficiency of medical and laboratory facilities.🔹 Collaborated with healthcare providers and laboratory operators to create custom facility plans, optimizing workflows and improving ergonomics.🔹 Ensured all designs met regulatory standards and incorporated state-of-the-art technology, delivering top-tier facilities to clients.🔹 Led cross-functional teams in the execution of complex healthcare projects, from initial concept through to completion.🔹 Developed risk management strategies to mitigate potential issues in the design and construction phases, ensuring project success.🔹 Managed stakeholder relationships, maintaining clear communication and transparency throughout the project lifecycle.🔹 Facilitated the implementation of best practices in facility planning, contributing to the advancement of healthcare infrastructure.
  • All-Ukrainian Association Of Sterilization And Disinfection
    Deputy Chairman
    All-Ukrainian Association Of Sterilization And Disinfection 2014 - Present
    Kyiv, Ukraine
    🔹 Led initiatives to raise public awareness on medical device reprocessing and sterilization, ensuring widespread understanding of best practices.🔹 Contributed to the drafting of national standards on the reprocessing and sterilization of medical devices, aligning with international guidelines.🔹 Represented Ukraine at the World Forum for Hospital Sterilization Supply (WFHSS), advocating for higher standards in sterilization and disinfection practices.🔹 Collaborated with healthcare institutions to implement effective sterilization protocols, improving patient safety across the country.🔹 Provided expert advice on the selection and use of sterilization technologies, ensuring compliance with health regulations.🔹 Organized training sessions for healthcare professionals, enhancing their skills in sterilization and disinfection procedures.🔹 Monitored developments in sterilization technology, ensuring Ukrainian standards kept pace with global advancements.🔹 Supported the development of a national certification program for sterilization professionals, contributing to the professionalization of the field.
  • International School Of Technical Legislation And Quality Management
    Expert Qms Auditor
    International School Of Technical Legislation And Quality Management Nov 2013 - Present
    Kiev
    🔹 Conducted comprehensive audits of laboratory facilities, assessing compliance with ISO 9001, ISO 15189, and ISO 17025 standards.🔹 Trained laboratory staff on quality management systems, ensuring thorough understanding and proper implementation.🔹 Evaluated laboratory layouts, engineering systems, and maintenance records, identifying areas for improvement and ensuring regulatory compliance.🔹 Developed corrective and preventative action plans to address audit findings, driving continuous improvement in laboratory operations.🔹 Facilitated communication between laboratory management and regulatory bodies, ensuring transparency and adherence to standards.🔹 Provided expert guidance on maintaining data integrity and quality within laboratory environments.🔹 Reviewed and updated standard operating procedures (SOPs) to align with best practices and regulatory requirements.🔹 Promoted a culture of excellence in laboratory operations, contributing to high standards of safety and quality.
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  • Naukma
    Senior Researcher
    Naukma Sep 2008 - Present
    🔹 Delivered high-level instruction in courses such as "Chemistry of Biological Processes," "Basics of Molecular Diagnostics," and "GMP and GLP," fostering academic excellence.🔹 Co-founded and taught the Master's program "Laboratory Diagnostics of Biological Systems," shaping the next generation of scientists and professionals.🔹 Developed and updated curricula, incorporating the latest research and industry standards to ensure relevant and impactful education.🔹 Supervised graduate research projects, providing mentorship and guidance to students in the Faculty of Natural Sciences.🔹 Conducted interdisciplinary research, contributing to advancements in molecular biology and cellular research.🔹 Collaborated with academic peers to enhance program offerings and ensure the university remained at the forefront of scientific education.🔹 Presented research findings at international conferences, establishing a strong academic reputation in the global scientific community.🔹 Supported the development of laboratory facilities within the university, aligning them with cutting-edge technologies and research needs.
  • World Health Organization
    Clean Room Consultant
    World Health Organization 2022 - Oct 2023
    Reinraumtechnik, Germany
    🔹 Provided expert consultation in the design, planning, and implementation of clean room facilities, ensuring strict adherence to GMP and electronic industry standards.🔹 Developed and optimized User Requirements Specifications (URS), clean room layouts, and Mechanical, Electrical, and Plumbing (MEP) plans to meet specific cleanliness levels.🔹 Spearheaded the integration of advanced environmental controls and monitoring systems, enhancing operational efficiency and regulatory compliance.🔹 Designed and validated HVAC systems tailored for clean rooms, ensuring precise temperature, humidity, and contamination control.🔹 Selected and validated construction materials that meet cleanliness standards, minimizing contamination risks in clean room environments.🔹 Led the preparation of validation documentation, including DQ, IQ, OQ, PQ protocols, ensuring comprehensive testing and compliance.🔹 Troubleshot complex issues during clean room construction and validation, providing actionable solutions to maintain project timelines.🔹 Supported continuous improvement initiatives, driving optimal performance and operational efficiency in clean room environments.
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  • Kintaro Cells Power International
    Director Of The Biotechnology Sector
    Kintaro Cells Power International Jun 2018 - Feb 2022
    Sea, Europe
    🔹 Lead the Biotechnology sector, driving innovative advancements in cell and molecular biology, biotechnology, and GMP manufacturing processes.🔹 Oversee the design and construction of cutting-edge laboratories, ensuring compliance with biosafety, biosecurity, and regulatory requirements.🔹 Implement rigorous risk analysis and quality management systems, optimizing operational efficiency and ensuring adherence to industry standards.🔹 Spearhead research initiatives in cell therapy and regenerative medicine, contributing to groundbreaking developments in the biotechnology field.🔹 Collaborate with international partners and regulatory bodies to maintain high standards of safety and efficacy in biotechnology applications.🔹 Direct the development and execution of strategic projects across Southeast Asia and Europe, expanding the company’s global presence.🔹 Mentor and guide a multidisciplinary team of scientists, fostering a culture of innovation and excellence in biotechnology research.🔹 Manage the integration of advanced technologies into laboratory practices, enhancing research outcomes and ensuring cutting-edge results.
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  • Ministry Of Health Of Ukraine
    Biosafety And Biosecurity Advisor
    Ministry Of Health Of Ukraine 2016 - Aug 2017
    Kyiv, Ukraine
    🔹 Advised the Ministry of Health on national biosafety and biosecurity strategies, ensuring alignment with international standards and best practices.🔹 Prepared and presented the national biosafety capacity-building strategy at the G7 meeting in Rome, Italy, representing Ukraine on a global stage.🔹 Developed policies and procedures to enhance biosafety and biosecurity within Ukrainian healthcare and laboratory facilities.🔹 Conducted risk assessments and audits to identify gaps in biosafety protocols, providing recommendations for improvement.🔹 Collaborated with international experts to implement advanced biosafety measures in Ukrainian laboratories.🔹 Provided training to healthcare professionals on biosafety and biosecurity, promoting a culture of safety and compliance.🔹 Monitored the implementation of biosafety initiatives, ensuring adherence to the national strategy and international obligations.🔹 Engaged with stakeholders across government and healthcare sectors to foster collaboration and support for biosafety initiatives.
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  • Sanitary Service Of Ukraine
    Secretary Of Public Council
    Sanitary Service Of Ukraine 2015 - 2016
    Kyiv, Ukraine
    🔹 Maintained comprehensive records of Public Council meetings, decisions, and discussions, ensuring transparency and accessibility for all stakeholders.🔹 Promoted public involvement in health and sanitation matters, facilitating open communication between the Sanitary Service and the public.🔹 Played a key role in enhancing the accountability of the State Sanitary Service through meticulous documentation and record-keeping.🔹 Coordinated with council members and stakeholders to ensure that decisions were effectively communicated and implemented.🔹 Supported initiatives aimed at improving public health and sanitation standards across Ukraine.🔹 Managed the dissemination of information to the public, ensuring clarity and consistency in all communications.🔹 Assisted in drafting policy recommendations based on council deliberations, contributing to the improvement of national health policies.🔹 Organized and facilitated public hearings, ensuring community voices were heard and considered in the decision-making process.
  • Gck
    Scientific Director
    Gck Jun 2009 - Dec 2011
    🔹 Led the planning and construction of a high-security biological laboratory and manufacturing facility, ensuring compliance with GMP class B standards.🔹 Directed the development of an experimental SPF-vivarium, enhancing research capabilities for mice and minipigs.🔹 Coordinated with international experts to implement cutting-edge technologies in the laboratory, positioning it as a leader in the field.🔹 Oversaw the validation and qualification of clean rooms, ensuring they met the highest standards of biosafety and operational efficiency.🔹 Managed the integration of advanced biosafety measures within the facility, minimizing risks and ensuring regulatory compliance.🔹 Provided scientific leadership throughout the project, guiding research priorities and ensuring alignment with strategic goals.🔹 Facilitated the recruitment and training of specialized staff, building a team capable of maintaining high standards in a complex laboratory environment.🔹 Monitored the construction process, ensuring timelines were met and the project adhered to budgetary constraints.
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  • Max Plank Institute Of Psychiatry, Munchen
    Visiting Phd Student
    Max Plank Institute Of Psychiatry, Munchen 2004 - 2006
    🔹 Conducted advanced research on the molecular biology of intracranial tumors, focusing on the mechanisms underlying tumor development and progression.🔹 Investigated the expression of TOLL receptors and members of the nuclear receptor superfamily in meningioma, contributing to a deeper understanding of tumor biology.🔹 Collaborated with leading researchers in the field, gaining valuable insights and expanding the scope of ongoing research projects.🔹 Utilized cutting-edge techniques in molecular biology to explore the role of specific receptors in tumor development, aiding in the identification of potential therapeutic targets.🔹 Presented research findings at international conferences, contributing to the global discourse on intracranial tumor biology.🔹 Published research results in peer-reviewed journals, enhancing the academic and scientific impact of the work conducted at the institute.🔹 Developed a strong foundation in experimental design and data analysis, skills that have been integral to subsequent research endeavors.🔹 Engaged in cross-disciplinary collaborations, broadening the scope of research and contributing to a holistic understanding of the molecular mechanisms at play in meningiomas.

Dr. Denys Bilko Education Details

Frequently Asked Questions about Dr. Denys Bilko

What company does Dr. Denys Bilko work for?

Dr. Denys Bilko works for International School Of Technical Legislation And Quality Management

What is Dr. Denys Bilko's role at the current company?

Dr. Denys Bilko's current role is Expert in Clean Room & Laboratory Planning | GMP Compliance Specialist | Biosafety & Laboratory Quality Management Consultant.

What schools did Dr. Denys Bilko attend?

Dr. Denys Bilko attended International School Of Technical Legislation, International School Of Technical Legislation And Quality Management, Kyiv-Mohyla Business School, Taras Shevchenko National University Of Kyiv, Taras Shevchenko National University Of Kyiv, The University Of Hull, Kiev # 277.

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