Олена

OLENA TSIVUN
Senior Process & Formulation Engineer | CMC | Technology Transfer |
Liquid & Semi-solid Dosage Forms

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SUMMARY
Senior Process & Formulation Engineer with 9+ years of experience in sterile injectable and liquid dosage form
development within ISO- and EU GMP-regulated pharmaceutical environments. Expertise in technology transfer,
process scale-up, lifecycle management, and commercial manufacturing implementation, including inter-site transfers.
Strong background in risk-based process control aligned with ICH Q8/Q9/Q10 and global regulatory expectations
(EMA, FDA, WHO). Proven ability to bridge R&D and commercial manufacturing to deliver robust, compliant, and
inspection-ready processes. Experienced in CPP/CQA strategy development, deviation investigation, CAPA
management, and preparation and review of CTD Module 3 documentation (“Pharmaceutical Development” and
“Manufacturing”). Supported technology transfer projects, global submissions, and post-approval process changes in
collaboration with cross-functional teams within GMP-regulated manufacturing environments.

EXPERIENCE
Jul 2022 – May 2026
Senior process & formulation engineer (R&D), LLC “Yuria-pharm”, Kyiv
• Led development, scale-up, and technology transfer of sterile injectable and liquid dosage form products in GMP-
regulated environments.
• Coordinated cross-functional activities and managed a team of 3 engineers to ensure successful project execution.
• Improved manufacturing robustness and reproducibility through optimisation of formulation and process parameters
across 10+ products.
• Conducted deviation investigations and supported CAPA implementation using structured RCA methodologies.
• Supported lifecycle management activities, including post-approval process changes and regulatory documentation
updates.
Mar 2020 – Jul 2022
Process & formulation engineer (R&D), LLC “Yuria-pharm”, Kyiv
• Supported technology transfer from R&D to production, including inter-site transfers.
• Conducted deviation investigations and process troubleshooting under GMP.
• Authored and compiled CTD Modules 3 (ENG/UKR) for Ukraine and international markets.
Dec 2017 - Feb 2020
Head of Soft & Liquid Dosage Forms Group (R&D), PJSC SIC “Borshchahivskiy CPP", Kyiv
• Effectively managed and coordinated the activities of the R&D group members.
• Successfully optimized the composition and production process for six pharmaceutical products.
• Developed QRM matrices for the production of injectable medicinal products (injection solutions, lyophilized
preparations, cephalosporin, and carbapenem antibiotics); oral medicinal products (syrups, suspensions); and topical
medicinal products.
• Conducted effective investigations to identify and prevent the causes of pharmaceutical product deviations.

EARLIER ROLES:
May 2017 – Nov 2017 Process & formulation engineer, PJSC SIC “Borshchahivskiy CPP", Kyiv
Jan 2016 – Apr 2017 Laboratory assistant, LLC “Elfa Laboratory”, Kyiv

EDUCATION
2014 – 2016 Master’s Degree in Chemical Technology
2010 – 2014 Bachelor’s Degree in Chemical Technology
National Technical University Of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”
2008 – 2010 Junior Specialist – Pharmacy
Kryvyi Rih Medical College

LANGUAGES
English – Upper Intermediate (B2)
Ukrainian – Native