Delivering end-to-end validation and qualification solutions across pharmaceutical and biotech industries — from design to full GMP compliance.
7+ Years experience | International projects | Risk-based approach
I am a Validation and Qualification Specialist with over 7 years of experience in pharmaceutical and medical device environments.
I support companies in ensuring that facilities, utilities, equipment, and processes meet GMP requirements — from early design stages through commissioning, qualification, and requalification.
My experience combines hands-on technical validation with a strong understanding of engineering systems, including HVAC, BMS, and critical utilities.
I have worked on international projects across Europe, the United States, and Asia, delivering solutions in complex, highly regulated environments.
- Airflow velocity measurements (UDAF / LAF)
- Air change rate (ACH) measurements - HVAC systems
- HEPA filter integrity testing (leak testing)
- Air cleanliness testing (particle counting)
- Differential pressure measurements (pressure cascade)
- Temperature & humidity mapping (thermal studies)
- Airflow visualization (smoke studies)
- Cleanroom recovery testing
- Cleanroom (HVAC) - C&Q and Requalification
- Laminar airflow systems (UDAF/LAF) - C&Q and Requalification
- Barrier systems (Isolators, RABS) - PV and Requalification
- Thermostatic equipment & CRT/CTT areas - C&Q and Requalification
- Cleanrooms and UDAF systems qualification
- Laboratory and process equipment qualification
- Execution of FAT / SAT / DQ / IQ / OQ / PQ
- Validation strategy and planning
- Risk-based approach (ICH Q9)
- Requalification and lifecycle management
- Isolators and H₂O₂ bio-decontamination
- Troubleshooting and system optimization
- URS, SOPs and validation documentation
- QMS development and implementation
- Deviations, CAPA, Change Control
- Risk & Impact Assessments
- Audit and inspection readiness
- Risk and CAPEX management
- HVAC systems and environmental monitoring
- BMS / FMS / EMS systems
- Utility systems (heating, cooling, water, gases)
- GMP and EU GMP Annex 1 compliance
Alongside managing end-to-end qualification lifecycle activities for cleanrooms, controlled temperature areas and equipment, I lead a cross-site project standardizing qualification and requalification procedures for HVAC systems,cleanrooms and thermostatic equipment across Polpharma Biologics sites in Gdańsk and Warsaw.
As a Work Package Owner, I was responsible for HVAC, BMS, EMS, FMS, Cold Storage and cleanroom systems in Recovery project, including design review, supplier selection, contract negotiations, contractor coordination and VPL preparation, ensuring compliance with GMP and EU GMP Annex 1 requirements.
As an international consultant during the Optima project, responsible for developing and performing bio-decontamination cycles validation of isolator lines and H2O2 systems for cleanroom technologies supporting pharmaceutical clients in China, Italy, USA, Denmark, Germany and Switzerland.
Consultant supporting development and implementation of QMS systems in compliance with ISO standards. Developing qualification documentation (DQ/IQ/ OQ/PQ) for cleanrooms, cold storage areas and process equipment.
Responsible for managing facility systems across 7 buildings including production areas, laboratories, warehouses and offices. Scope included maintenance supervision, qualification activities and CAPA implementation.
Responsible for conceptual, construction and detailed design of HVAC systems for hospital renovation projects, including airflow measurements and adjustment of ventilation parameters.
Sales Engineer responsible for selection of refrigeration equipment and management of technical communication with international clients and manufacturers.
Supporting design of HVAC and utilities sytems for major commercial projects: Bloomberg Palace, London; Norway House, Warsaw; Browary Warszawskie, Warsaw.
Available for project-based engagements, long-term contracts, and ongoing validation support. Get in touch to discuss your facility's needs.