I am a Validation and Qualification Expert with over 7 years of experience in pharmaceutical and medical device industries, supporting projects across Europe, the United States, and Asia.
I specialize in the full lifecycle of validation and qualification activities — from system design and commissioning through DQ, IQ, OQ, PQ, and requalification — ensuring compliance with GMP requirements and industry standards.
My expertise includes facility utilities (HVAC, BMS, FMS), equipment qualification, and advanced process validation, particularly in isolator systems and H₂O₂ bio-decontamination. I apply a risk-based approach (ICH Q9) to develop robust and efficient validation strategies.
I have worked with leading organizations such as Thermo Fisher Scientific, Novo Nordisk, Lonza, and Polpharma, delivering projects in complex, highly regulated environments.
My background also includes design and construction engineering, giving me a strong understanding of the full system lifecycle — from concept and installation to commissioning and qualification.
I am passionate about delivering practical, compliant, and risk-based solutions that ensure systems are not only validated, but also reliable and audit-ready.
Work with meWarsaw University of Technology · 2019
Warsaw University of Technology · 2019
International Society for Pharmaceutical Engineering
Operational license of fluorinated gas systems.
Supervisor License of Electricity, Heat, Gas equipment, and installations.
PDA Training · 2020
Industry Training · 2020
Solid dose, sterile injectables, API manufacturing, OSD facilities.
Biologics, cell & gene therapy, fermentation, fill-finish operations.
ISO 5–8 classified environments, controlled areas, containment suites.
FDA 21 CFR Part 820, ISO 13485, design & process validation.
CMO/CDMO environments, multi-product facilities, tech transfer support.
Early-phase facilities, lab qualification, scale-up to commercial.