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About Me

The woman
behind the protocols.

Background
portrait
Based in Warsaw, Poland
Available for Hybrid & Remote
Languages English, Polish
Experience 7+ Years
Contact katarzyna.szkodzinska11@gmail.com

A career built on getting it right the first time.

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.


dym Work with me
Key Competencies

What I bring to the table.


Validation Strategy & Lifecycle (CQV)

  • FAT / SAT / DQ / IQ / OQ / PQ execution & cordination
  • Validation strategy development & planning
  • Risk-based approach (ICH Q9)
  • Requalification & lifecycle management
  • Validation Master Plan (VMP) authoring
  • Process Performance Qualification (PPQ)

HVAC & Utilities

  • ISO 14644 Cleanroom qualification
  • HVAC qualification & performance testing
  • Cleanroom classification & enviromental monitoring
  • Pressure differential mapping
  • Airflow visualisation (smoke studies)
  • UDAFfication
  • HEPA filter integrity testing
  • Temperature & humidity mapping (unif qualiormity)
  • Warehouse & Storage qualification

GMP Compliance & Risk Management

  • FDA 21 CFR Parts 210, 211, 820
  • EU GMP Annex 1, 11, 15
  • ICH Q8, Q9, Q10 guidelines
  • Risk Assesment (ICH9, FMEA)
  • Pre-inspection gap assessments
  • Deviation management & CAPA
  • Change control & Impact Assessment

Validation Documentation & QMS

  • Validation Protocol & report authoring
  • SOP development & lifcycle management revision
  • Risk assessment (FMEA, HACCP)
  • Electronic quality management systems (eQMS)
  • Change control management
  • Technical review & expertise
Credentials

Education & qualifications


Education

🎓

Master of Science Degree in Construction Engineering Specialty Utilities Systems

Warsaw University of Technology · 2019

📘

Engineer Degree in Heating, Cooling, Ventilation, and Gas Industry

Warsaw University of Technology · 2019

🌐

ISPE Member

International Society for Pharmaceutical Engineering



Licenses

🎓

F-Gases

Operational license of fluorinated gas systems.

📋

SEP cat. G1/G2/G3

Supervisor License of Electricity, Heat, Gas equipment, and installations.

⚗️

ICH Q9 Quality Risk Management

PDA Training · 2020

🏭

EU GMP Annex 1 Sterile Manufacture

Industry Training · 2020

Sectors

Industries I've worked in.


💊

Pharmaceutical

Solid dose, sterile injectables, API manufacturing, OSD facilities.

🧬

Biotechnology

Biologics, cell & gene therapy, fermentation, fill-finish operations.

🌡️

HVAC & Cleanrooms

ISO 5–8 classified environments, controlled areas, containment suites.

🏥

Medical Devices

FDA 21 CFR Part 820, ISO 13485, design & process validation.

🧪

Contract Manufacturing

CMO/CDMO environments, multi-product facilities, tech transfer support.

🔬

Research & Development

Early-phase facilities, lab qualification, scale-up to commercial.

Ready to work together?

Get in Touch