Karolina is a Strategic CQV, CSV, and CAPEX leader with 9+ years of experience in pharmaceutical, biopharmaceutical, and medical device manufacturing. She has demonstrated success in delivering high-risk, regulator-driven capital projects, restoring compliance in challenged GMP environments, and developing high-performing multidisciplinary teams across diverse dosage forms.
She brings deep expertise across pMDIs, liquids and creams, solid oral dosage forms, sterile and non-sterile products, and medical devices, supported by a strong engineering foundation and advanced quality and validation knowledge. She is known for driving effective, risk-based decision-making at the intersection of Engineering, QA, and Manufacturing.
Karolina is a recognized industry contributor and ISPE-approved trainer in Commissioning & Qualification, committed to advancing best practices and shaping the future of pharmaceutical engineering excellence.
