Credentials

Gregor Gantar

Principal Process Engineer · Aseptic Fill-Finish SME

15+ years of specialist experience in sterile pharmaceutical manufacturing across Slovenia, Switzerland, and Australia. Deep technical expertise in aseptic fill-finish, Annex 1 CCS, and CQV programme management.

Gregor Gantar
Available Now

Education

Bachelor of Electrical Engineering
University of Ljubljana, Slovenia
Focus: Automation & Process Control

Certifications

Lean Six Sigma Green Belt
EU GMP Annex 1 (2023) — CCS Implementation
ISPE Member
PIC/S GMP Trained
ABN: 46 730 540 268 (Registered Sole Trader)
PI & PL Insurance (available on request)

Career History

CSL Behring
Principal Process Engineer
Melbourne, Australia · 2022 – Present

Leading the BACE II biologics fill-finish expansion project. Responsible for CCS development, CQV programme management, and aseptic process engineering.

ATP CG Pharm Group
Senior Consultant
Switzerland · 2022

Pharmaceutical engineering consulting for sterile manufacturing clients across Europe.

SKAN AG
Consulting Engineer
Switzerland · 2022

Specialist isolator qualification and aseptic process development support.

Lonza AG
Process Engineer
Switzerland · 2021 – 2022

Technology transfer and process engineering at one of the world's leading pharmaceutical CDMOs.

Novartis TechOps
Senior Process Engineer
Ljubljana, Slovenia · 2015 – 2021

Six years of process engineering and optimisation across multiple sterile fill-finish lines. Delivered €1M+ in cost savings through Lean Six Sigma programmes.

Sandoz / Lek d.d.
Process Engineer
Ljubljana, Slovenia · 2011 – 2015

Foundation experience in aseptic fill-finish operations, equipment qualification, and GMP quality systems.

Technical Skills

Aseptic Fill-Finish (vials, PFS, cartridges)
Isolator & RABS technology
Contamination Control Strategy (CCS)
Commissioning, Qualification & Validation (CQV)
Environmental Monitoring Programme design
Aseptic Process Simulation (media fill)
Lyophilisation (freeze-drying)
Clean utilities (WFI, clean steam, purified water)
HVAC design and qualification
Lean Six Sigma (Green Belt)
Process capability analysis (Cpk, Ppk)
Root cause analysis & CAPA
Technical writing and documentation
AI-assisted engineering tools

Regulatory Frameworks

EU GMP Annex 1 (2023)
Expert
TGA (Australian)
Expert
FDA 21 CFR Parts 210/211
Proficient
EMA Guidelines
Expert
ANVISA (Brazil)
Proficient
ICH Q10 / Q9 / Q8
Expert
PIC/S GMP
Expert
ISO 14644 (Cleanrooms)
Expert

References available on request

Professional references from CSL Behring, Novartis TechOps, and Sandoz are available upon request for serious enquiries.

Request References
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