Project Experience
Real projects, real outcomes. Our team has delivered across some of the world's most demanding sterile manufacturing environments.
CSL Behring
Led the engineering and CQV workstream for the BACE II biologics fill-finish expansion — one of Australia's largest sterile manufacturing capital projects.
Key Outcomes
- Developed the site Contamination Control Strategy (CCS) aligned with EU GMP Annex 1 (2023)
- Led CQV programme for new isolator-based filling line
- Managed cross-functional team of 15+ engineers and validation specialists
- Delivered project milestones on schedule within a AUD 100M+ capital programme
- Established aseptic process simulation (media fill) programme
Novartis TechOps
Drove process optimisation and Lean Six Sigma programmes across multiple sterile manufacturing lines, delivering significant yield improvements and cost savings.
Key Outcomes
- Delivered €1M+ in documented cost savings through process optimisation
- Led Lean Six Sigma Green Belt projects across vial and syringe filling lines
- Supported TGA and EMA inspection readiness programmes
- Implemented OEE improvement programme — 15%+ uplift across key lines
- Authored and executed qualification protocols for critical equipment
Lonza AG
Supported technology transfer and process engineering activities at one of the world's leading pharmaceutical CDMOs.
Key Outcomes
- Managed technology transfer for sterile drug product from client to Lonza facility
- Developed and executed process validation protocols
- Supported regulatory submissions for new product introductions
- Collaborated with international client teams across EU and US time zones
Sandoz / Lek d.d.
Built foundational expertise in aseptic fill-finish operations and GMP quality systems at a major global generics manufacturer.
Key Outcomes
- Qualified and validated aseptic filling equipment for vials and ampoules
- Developed SOPs and batch records for new product introductions
- Participated in TGA and EMA regulatory inspections
- Implemented environmental monitoring improvements in Grade A/B areas
SKAN AG
Specialist engagement supporting isolator qualification and aseptic process development for a leading isolator manufacturer.
Key Outcomes
- Supported isolator qualification and validation activities
- Developed technical documentation for isolator-based filling systems
- Provided expert input on aseptic process design
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