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Sébastien BILS

RUEIL MALMAISON

En résumé

Following cell Culture and Purification steps (USP-DSP)
Cleaning validations.
Projects managing like alarm rationalisation, sampling optimization, Delta V automation debottleneck, DSP closed system, disposables improvement
Technical support to production for Change Control and deviations management.
Work according to GMP's and in controlled area.
Computing: Visio, DeltaV, SAP, TrackWise, Office.
Experience of implementation of a new production unit

Mes compétences :
Cell Culture
DeltaV
integrity testing
process control analysis
deviations management
alarm management
TrackWise
Technical support
SAP OFFICE
SAP
Microsoft Visio
IQ OQ PQ
Environmental Monitoring
Dosage Forms
DSP
Continuous Improvement
Cleaning Validation
Change Management
Antibody

Entreprises

  • Novartis - Process Specialist

    RUEIL MALMAISON 2012 - maintenant Technical support to production for deviations, change controls, documentary
    changes, planning, environmental monitoring.
    - Batch record review.
    - Redaction of cleaning validation reports. ;
    - Continuous improvement in documentation (RFT), automation (DeltaV program),
    technician's training, disposables (bags, assembly).
    - Backup of the process coordinator.

  • Novartis - Process Specialist

    RUEIL MALMAISON 2012 - maintenant Technical support to production for deviations, change controls, documentary
    changes, planning, environmental monitoring.
    - Batch record review.
    - Redaction of cleaning validation reports. ;
    - Continuous improvement in documentation (RFT), automation (DeltaV program),
    technician's training, disposables (bags, assembly).
    - Backup of the process coordinator.

  • Novartis - Process Technician

    RUEIL MALMAISON 2008 - 2012 Implementation of a new production unit: order and qualification of equipment,
    drafting documents such as manufacturing records and working procedures.
    - DQ, IQ, OQ and PQ of bioreactors, CIP stations, small equipments. ;
    - Realization of the cell culture and protein purification steps (thawing of cryovials,
    laminar flow, automatized equipments), environmental controls, integrity testing.
    - Batch record review.

  • Novartis - Process Technician

    RUEIL MALMAISON 2008 - 2012 Implementation of a new production unit: order and qualification of equipment,
    drafting documents such as manufacturing records and working procedures.
    - DQ, IQ, OQ and PQ of bioreactors, CIP stations, small equipments. ;
    - Realization of the cell culture and protein purification steps (thawing of cryovials,
    laminar flow, automatized equipments), environmental controls, integrity testing.
    - Batch record review.

  • Novartis - Process Biotechnician

    RUEIL MALMAISON 2006 - 2008 Cell culture in large scale.
    - In-process control analysis.
    - Batch record review.

  • Novartis - Biotechnicien

    RUEIL MALMAISON 2006 - 2008 Cell culture in large scale.
    - In-process control analysis.
    - Batch record review.

  • Eli Lilly - Technician

    neuilly sur seine 2005 - 2006 Mobile isolators management (NaOH decontamination, planning). ;
    - Sterile filling drug cartridges under isolators. ;
    - Loading filling lines under isolators.

  • Eli Lilly - Technician

    neuilly sur seine 2005 - 2006 Mobile isolators management (NaOH decontamination, planning). ;
    - Sterile filling drug cartridges under isolators. ;
    - Loading filling lines under isolators.

  • Eli Lilly - Operator & Technician

    neuilly sur seine 1998 - 2005 Washing and sterilization of tanks and small parts for insulin and cytotoxics. ;
    - Washing and decontamination of mobile isolators for cytotoxics. ;
    - Integrity testing of steriles filters.

  • Eli Lilly - Operator & Technician

    neuilly sur seine 1998 - 2005 Washing and sterilization of tanks and small parts for insulin and cytotoxics. ;
    - Washing and decontamination of mobile isolators for cytotoxics. ;
    - Integrity testing of steriles filters.

Formations

  • Groupe IMT

    Tours 2004 - 2005 TPI

    work on production of different products, in different dosage forms

  • Groupe IMT

    Tours 2004 - 2005 TPI

    work on production of different products, in different dosage forms

Réseau

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