Team

Thomas Lederer
– SME in Projekt Management, Engineering Management, Construction Management sowie in HVAC, Reinraum- und Gebäudetechnik
– 20+ Jahre an Erfahrung in der Planung, im Bau, in der IBN und Qualifizierung von Anlagen in der pharmazeutischen Industrie
Management of CAPEX projects up to a volume of CHF 300 million and across all project phases.
Experience in lean methodologies and IPD (Integraded Project Delivery)
Selection of references: Lonza, Novartis, Takeda, Emergent, Alcon, Wacker, Astellas, UCB, Merck

Gaëlle Berthoud
- Biotech process expertise
- USP and DSP
- From lab scale to large scale production
- Process Development
- Process Improvement
- Single Use expertise
- BOM creation and management

Corrado Melis
- Process Improvement
- Serialization and tamper evident
- Expert in Qualification (Trackwise, Kneat, etc)
- SCADA, DELTA V, Siemens and Rockwell automation
- Cleaning Room Construction
- SAP ERP Expert for maintenance processes

Andrew Jones
- Leading ATMP & biologics GMP operations
- Manufacturing SME incl. Tech Transfer, ATMPs & Sterility Assurance
- Project Management incl. tech transfer, infrastructure & licensing
- Compliance Improvement & Auditing

Christian Fimbel
Senior Construction Manager

Valerie Amsler
Process Ingenieur

Confidential

Confidential
Process engineer

Thomas Lederer
- SME in project management, engineering management, construction management as well as HVAC, clean room and building technology
- 20+ years of experience in the planning, construction, IBN and qualification of plants in the pharmaceutical industry
- Management of CAPEX projects up to a volume of CHF 300 million and across all project phases.
- Experience in lean methodologies and IPD (Integraded Project Delivery)
- Selection of references: Lonza, Novartis, Takeda, Emergent, Alcon, Wacker, Astellas, UCB, Merck

Corrado Melis
- Process Improvement
- Serialization and tamper evident
- Expert in qualification (Trackwise, Kneat GT, etc)
- SCADA, DELTA V, Siemens and Rockwell automation
- Cleaning Room Construction
- SAP ERP Expert for maintenance processes

Confidential
- Experience and knowledge in the qualification and validation of pharmaceutical plants and in the handling and use of CQV tools such as Trackwise, KNEAT and Documentum
- Experience in document management, project administration and project coordination, in the use of lean methodologies and in process optimization

Andrew Johnes
- Leading ATMP & biologics GMP operations
- Manufacturing SME incl. Tech Transfer, ATMPs & Sterility Assurance
- Project Management incl. tech transfer, infrastructure & licensing
- Compliance Improvement & Auditing

Confidential
Process engineer

Gaëlle Berthoud
- Biotech process expertise
- USP and DSP
- From lab scale to large scale production
- Process Development
- Process Improvement
- Single Use expertise
- BOM creation and management

Confidential
HSE Expert
Our expertise


Partner



Refine AG
- IPD, Last Planner, Lean Construction, Bim -
Hardturmstrasse 76
8005 Zurich



Organizations
