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

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

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

Daniel Schönemann
- 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

Confidential
Process engineer

Confidential
Senior Process Ingenieurin

Confidential
Project Manager

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

Daniel Schönemann
- 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
Senior Prozess Ingenieurin

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
Process engineer
Our expertise


Partner



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



Organizations
