Stefano Genesio Email & Phone Number

Milan, It

Milan, Lombardy, Italy

Milan, Lombardy, Italy

In charge to develop and lead Managed Services, CQV and OTS group in Western Europe to continue supporting international clients and strategic projects within the Pharmaceuticals, Medtech, Advanced Manufacturing and Data Centre sectors.

Responsible for CQV and Regulatory Compliance operations in Europe leading a group of 160 resources located in Italy, Switzerland, Germany, Ireland, UK and Scandinavia. Main duties and responsibilities:• Define the road map for strategic growth of the CQV business in the Mainland Europe, Ireland, UK and Scandinavia• Identify, select and hire key CQV resources (staff) and senior external consultants• Support Sales departments and PMs to define the CQV scope of work and budget definition for new prospects, including technical presentation for large and complex projects • Responsible for the Engineering Compliance of projects with applicable guidelines• Responsible for the P&L of CQV group performances in Europe (160 resources)• Act as sponsor on complex projects, supporting the C&Q project strategy definition based on the specific manufacturing facility, client guidelines and applicable regulation• Identify and implement new approaches to optimize the Construction, Commissioning and Qualification activities in line with applicable standards and guidelines• CQV and Regulatory Compliance business development• CQV Paperless software identification on specific projects (ValGenesis, EIDA, Kneat, Endeavour, etc.)• Support the CQV operation in Life Science, Building & Infrastructure and Electronics & Datacenter markets• Re-define the CQV strategy with the “new way-of-doing” (ISPE and ASTM)

Milan Area, Italy

Targets achieved within the first 18 months as CQV Director for Mainland Europe:• Set-up of the CQV Department in Italy (Milan), hiring multiple senior CQV resources (staff and consultants) including the Manager of CQV dept.• Set-up of the CQV Department in Switzerland (Basel) and Germany, hiring multiple CQV resources (staff and consultants) including the Manager of CQV dept.• Strong network of 45+ external consultants working on Jacobs projects in the Mainland Europe• Standardization and harmonization of Work Procedures (WP) and Work Instruction (WI) between the global Jacobs organization (US, Ireland, Mainland Europe and India)• Alignment on high-level CQV procedures between different offices• Training of CQV Managers and Senior CQV Engineers to Jacobs standards and guidelines• Implementation of CQV Paperless software on multiple projects• Strong Backlog awarded for CQV and Regulatory Compliance group

Milan Area, Italy

C&Q Manager at Teva Pharmaceuticals, Ulm (Germany)New biotech plant in UlmProject Manager at Pfizer, KAEC - Jeddah/KAEC (Saudi Arabia)In charge as client Project Manager coordinating the Main Contractor up to the final mechanical completion of the new OSD facility including the start-up, commissioning and qualification activities (TIC > 60 M $)Preparation of:• High level validation strategy• Validation and Commissioning Master Plan (VMP, CMP)• Turn-Over System (TOS) battery limits definition• Scheduling and KPI definition• project management monthly report• Template definition and review of principal commissioning and qualification protocols for all clean utilities, process equipment and automation systems.• Weekly/monthly review• Technological transfer support• Cost control and mhrs assignment review/forecast reportSME for high level technical problem solving and client representative during the Saudi FDA inspection.Previous projects:- C&Q Project Manager at Biogen Idec, Hillerod (Denmark)- C&Q Manager at Novartis S.A., Nyon (Switzerland)- Commissioning Manager at Chiesi Farmaceutici S.p.A., Parma (Italy)- C&Q Manager at GSK Bio (WN158), Wavre (Belgium)Essential duties: • Prepare and finalize the commissioning and qualification strategy of the project and assure its implementation throughout the entire project life-cycle (CMP/VMP, SLIA/CLIA, Turn-Over System strategy, Commissioning & Qualification Protocols, etc.);• Ensure the preparation of the project deliverables, their consistency with user/contract requirements;• Ensure the compliance of the assigned budget in terms of man-hours;• Interface the Engineering Department, Client and Vendor representatives in the execution of the project.

Milan Area, Italy

- Project Manager at Richter Gedeon - Budapest and Debrecen site (Hungary)- Validation Leader at HBP/KEDRION Group - Godollo (Hungary)- Project Leader at Guardian Drug Company - New Jersey (USA) - Commissioning and qualification of production equipment.- Project Leader at Procos S.p.A. - Novara (Italy) - Commissioning and qualification of new production area. - Project Leader at GUNA S.p.A. - Milano (Italy) - Commissioning and qualification all equipment of new building in Milan, utilities and equipment.- Project Engineer at Eli Lilly S.p.A. - Firenze (Italy) - Commissioning of Plant utilities (SAT) and Qualification (IQ, OQ and PQ) of Clean utilities ( PW, WFI, Clean Steam, ...) writing, compilation and execution.- Project Engineer at GSK - Godollo (Hungary) - Commissioning and Qualification of Media Preparation Area.

Florence Area, Italy

Rome Area, Italy

- Building supervision systems (SCADA) to control HVAC and safety systems for the new expansion of Spallanzani Hospital in Rome- First experience abroad as Commissioning & Validation engineer in a pharmaceutical project for GSK site in Budapest (Media Preparation and Sterilization, Washing Machine, Detoxification...).