Yaroslava Pirkovets
Bergen
Summary
Experienced validation engineer with expertise in GMP compliance, risk assessment, and corrective and preventive action (CAPA) management. He has a proven track record of developing comprehensive validation protocols, improving product quality, and ensuring regulatory compliance. He has successfully implemented continuous improvement initiatives, resulting in cost savings and quality improvements. He is committed to ensuring compliance with GMP, FDA, and ISO standards.
Overview
4
4
years of professional experience
Work History
Validation Engineer
Validation Center
Kharkiv
01.2024 - 03.2026
- Development of qualification and re-qualification protocols (DQ, IQ, OQ, PQ) for manufacturing equipment (reactor lines, sterilizers, depyrogenation tunnels, all types of production lines, and the like), laboratory equipment (chromatographs, balances, centrifuges, titrators, and the like), utility systems (water treatment systems, compressed air, nitrogen, clean steam systems), computerized systems, and cleanrooms.
- Development of validation protocols for manufacturing, cleaning, and packaging processes.
- Ability to work with GMP, ISPE, ISO, and FDA standards.
- Implemented continuous improvement initiatives for validation processes, leading to enhanced product quality and cost savings.
- Conducting risk assessments of proposed changes and documenting change management results in accordance with validation requirements.
- Identifying and documenting deviations, and developing corrective actions to address deviations. Conducting investigations.
Preparing documentation required for qualification and validation (validation master plan, risk analysis, qualification and validation protocols, standard operating procedures, documentation of deviations). - Preparing documentation for FAT and SAT tests, as well as conducting these tests.
- Working with equipment, facilities, and systems (conducting all necessary tests for qualification, validation, and commissioning).
Working with MadgeTech 4, TSI, Kanomax, MetOne, ATI, Testo, and Huato software and equipment. - Knowledge of software packages and applications: MS Office, Adobe Acrobat, Paint.Net, Internet Explorer, MS Visio, MS.
- Ensuring regulatory compliance—ensuring that validation activities comply with GMP, GAMP, FDA, EMA, and internal company standards.
- Extensive experience traveling on business both within Ukraine and abroad (Romania, Kazakhstan, Kyrgyzstan).
- Contributed to successful audits by providing detailed validation documentation and addressing any regulatory findings promptly.
Validation Engineer
Sytenko Institute of Spine and Joint Pathology of the National Academy of Medical Sciences of Ukraine
Kharkiv
08.2022 - 04.2023
- Developed and executed validation protocols for software and systems to ensure compliance with industry standards.
- Analyzed test data to validate system performance and reliability, ensuring alignment with specifications.
- Documented validation results and prepared comprehensive reports for stakeholder review and compliance purposes.
- Assisted in training junior engineers on validation methodologies and best practices within the team.
- Development of qualification and re-qualification protocols (DQ, IQ, OQ, PQ) for laboratory equipment (chromatographs, balances, centrifuges, titrators, and the like), utility systems (water treatment systems, compressed air, nitrogen, clean steam systems), computerized systems.
- Development of validation protocols for manufacturing, cleaning, and packaging processes.
- Ability to work with GMP, ISPE, ISO, and FDA standards.
- Conducting risk assessments of proposed changes and documenting change management results in accordance with validation requirements.
- Identifying and documenting deviations, and developing corrective actions to address deviations. Conducting investigations.
Preparing documentation required for qualification and validation.
Education
Master of Science - Biomedical Engineering
National Aerospace University «Kharkiv Aviation Institute»
Kharkiv12-2024
Bachelor of Science - Biomedical Engineering
National Aerospace University «Kharkiv Aviation Institute»
Kharkiv06-2023
GED -
Sumy Specialized School No. 17 of I-III Grades, Sumy City Co
Sumy06-2019
Skills
- Effective communication
- Equipment qualification
- Testing protocols (DQ, IQ, OQ, PQ, PV)
- CAPA management
- Process validation
- Measurements and analysis
- Engineering systems testing
- ISO standards
- GMP compliance
- Report writing
- Teamwork
- Risk assessment
- Corrective action planning
- Work with measuring equipment
Languages
English
Full Professional
Ukrainian
Native or Bilingual
Polish
Professional Working
Russian
Native or Bilingual
Timeline
Validation Engineer
Validation Center
01.2024 - 03.2026
Validation Engineer
Sytenko Institute of Spine and Joint Pathology of the National Academy of Medical Sciences of Ukraine
08.2022 - 04.2023
Master of Science - Biomedical Engineering
National Aerospace University «Kharkiv Aviation Institute»
Bachelor of Science - Biomedical Engineering
National Aerospace University «Kharkiv Aviation Institute»
GED -
Sumy Specialized School No. 17 of I-III Grades, Sumy City Co