• Nationality:
      Italian
    • Residence:
      Lyss
    Native
    Italian
    Fluent
    English
    A2/B1
    German
    Construction supervision - CSA
    Machinery directive - 42/2006/EU - EKAS
    Life Science / Pharma
    Fire protection (VKF -SUVA)
    Javascript
    Clean and Black Uilities CQV
    CAPEX - CAPA - Deviations
    GMP - GDP - GxP
    Risk analysis – 12100:2010
    HTML - CSS

    Experiences

      Lonza-Sanofi/ BioAtrium -Visp

      Nov 2022 - Current

      Role: Plant engineer and TCR manager
      Key responsibilities:

    • Plant and CAPEX engineer

      Production (USP and DSP) and clean utilities maintenance planning; CAPEX management till 500K CHF;

      Requalification and qualification activities (FAT-SAT-IQ-OQ) for USP/ DSP/Clean Utilites equipment/process. Smoke studies preparation and execution supervision for qualification activities.

      Low bioburden endfill unit maintenance and CAPEX project coordination for implementation SME.

      Technical Change Request coordinator; daily use of SAP, Excel, COMOS, DMS, TrackWise, GMP standards.

      Experience with Swissmedic audit for production license.

      Daily and weekly alignment with Department stakeholders to discuss Technical Changes related to all BioAtrium departments.

      Biogen – Solothurn (SO)

      Aug 2018 – March 2020

      Role: Construction Engineer // Machinery and PED directive
      Key responsibilities:

    • Coordination of all process relevant activities incl. review and approve process engineering specifications, including process piping & instrumentation diagrams (P&IDs), datasheets, and procurement packages for quipment and systems.

      Close collaboration with all project discipline (incl. Contactors), key Project & Site stakeholders and project managers.

      Interface with stakeholders to ensure the design execution and delivery are in accordance with Global Engineering, Quality, Environmental and Safety procedures.

      Integral test planner and executor for final building occupancy.

      Inspections with SGV, AWA/SUVA, AfU for final building acceptance (fire protection approval for the building insurance, environmental office and work insurance department)

      Fire protection requirements construction supervisor (QS brandschutz support).

      Compliance supervision according to local and European fire protection directives (VKF/AEAI – FM global for sprinkler system).

      TUV Sud Basel consultant support on machinery directive procedures for documental compliance with MD 2006/42/EC and 2014/68/EU and EKAS requirements.

      Scheduler and coordinator for cantonal inspections (AWA, SUVA, SGV, FM global, AfU).

      Lightning protection system coordination for final cantonal approval.

      GSK vaccines – Siena (ITALY)

      Nov 2016 – Aug 2018

      Role: Engineering-process consultant // CQV Clean Utilities and Maintenance
      Key responsibilities:

    • URS definition for clean utilities production plant revamping (Ultrafiltration system, Softened water system, Purified water system (double stage reverse osmosis equipment ), Water for injection (5 stages distillator equipment), clean steam generator. Clean gasses (CO2, O2, N2, He) storage and distribution.

      Clean utilities installation (FAT/SAT) and qualification (IQ,OQ) execution and supervision.

      Instrument calibration planning and supervision (support to relevant project manager)- KAYE validator for temperature mapping.

      Performance qualification (PQ) supervision, GMP deviations and gap assessment execution for all the equipment and relevant mechanical interconnections related to the clean utilities mentioned above according to GMP, FDA and AIFA requirements.

      Commissioning supervision. PW (purified water), WFI (water for injection) loops sanification process tuning during IQ-OQ using Delta-V and OSI PI software.

      Monitor external service providers, participate in internal audits, and serve as SME for production issues.

      Capture and maintain consistent data on technical systems (spare parts lists, operating instructions, Clean utilities SOPs creation, technical documentation request and revision)

      Clean utilities maintenance department : activity planner, Start up/shut down scheduler, spare part list creation and client support with vendors’/suppliers’ contact for ordinary and not-ordinary maintenance.

      Pharmaceutical, Chemical, Food and Mechanical companies

      Jan 2016 – Nov 2016

      Role: Engineering-process consultant // Machinery and PED directive
      Key responsibilities:

    • Pressurized equipment compliance check with D.M. 329/2004, 97/32/CE (P.E.D.) and D.Lgs. 26/2016 – ISO 9001 and 2014/68/EU.

      Equipment and assembly of machineries authorities registration according to D.Lgs. 17/2010.

      Compliance, design and revamping of pressurized equipment (ASTM e ISPESL directives, ASME for piping and equimpent).

      Operating manuals creation for equipment according to machinery directive (D.Lgs 17/2010) and 2006/42/ European directive.

      Execution of risk analysis according to local D.Lgs. (81/2008) and EN 12100.

    Studies

      Jan 2018

    • Seminary - Treatment of water in heating systems and sanitary circuits according to current legislation as a tool for energy efficiency

      Jan 2015

    • Trainer .Tech Training Course

      Jun 2008

    • High scool diploma

       Liceo Scientifico F.Severi (FR)

      72/110

      Mar 2006

    • Swim teacher - 1st level

      F.I.N. Roma

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