Julia DENY

En résumé

Entreprises

• GSK Biologicals (Wavre, Belgium) - Ingénieur Validation Process Control

  2011 - 2015  Coordination of the validation of automated production equipment (Bulk) for 2 new facilities (Inactivated Polio Virus and Pertussis), using Delta V, and applying the ASTM E2500 approach: inactivation skids, fermentation skids, media and buffer vessels, Chromatography controllers
   Coordination of the validation of automated production equipment (Formulation) using Delta V, with IQ/OQ approach
   Coordination of the validation of automated equipment using Siemens PLCs: washing machines, autoclaves, Purified Water, Pure Steam and Water For Injection generators, MAL Dry Fog
   Coordination of the validation of the automation of fully-automated visual inspection equipment (Seidenader)
   Periodic review of supplier audits (reports and assessments to identify additional audits required)
   Coordination of the Validation of a computerised system for automated versioning and comparison of PLC programs (Versiondog)
   Change Control on a Site Alarm management system
   SOPs assessments (site SOPs vs. Corporate SOPs)
   Writing of BLAs (Biologics Licence Application) – scope limited to automated and computerized systems
   Reporting of KPIs
  
  Main achievements:
  - Application of the ASTM E2500 approach, methodology defined as the projects went along. Key aspects are the design reviews, risks assessment, change control, and supplier audits
  - First experience with automated production systems such as PLCs and Delta V
  - Risk-based approach applied to testing scope, leveraging assessments, system release, incident and change management
  - Coordination of many people for a large number of equipment : suppliers, GSK engineers, engineering offices, test execution contractors, users, Quality Assurance, GSK experts and management, Mechanical and Process validation coordinators, in order to have automation programs meeting everyone’s needs, to align the methodology, and to meet the project deadlines
  - Use of a Project Documentation management system (Agora)
  - Coaching / Training of fellow Computer Systems Validation coordinators
  

• Hospira Australia (Melbourne) - Ingénieur Validation des Equipements de Laboratoire et LIMS

  2010 - 2010 Hospira Australia is the Australian branch of Hospira, an American company headquartered in Lake Forest, Illinois, USA that manufactures specialty generic injectable pharmaceuticals.
  As a validation engineer working for the Laboratory Management Department on Mulgrave site, I was in charge of carrying out full validation cycles of new automated laboratory equipment, of the validation of the new Automated Packaging Components Analyser and I was also involved in the evaluation and validation of the Raw Material and Finished Products modules of the LIMS project.
  
   Implementation and Validation of a UV-Visible Spectrophotometer, a Polarimeter, a Particle Analyser Zetasizer (measure of particle size and zetapotential), a TLC Applicator
   Evaluation and Risk Assessment for the Raw Material and the Finished Product modules of Nova-LIMS
   Evaluation, Risk Assessment, IQ and OQ Preparation and Execution, PQ Preparation of the APCA (Automated Packaging Components Analyser)
  
  Main achievements:
  - Adapting to a new type of environment such as a laboratory (as opposed to Production): GLP, terminology, processes, laboratory documentation
  - Getting familiar (to a very technical level) with various laboratory equipment by interacting with vendors, technical experts, witnessing IQ and OQ testing, and providing assistance to users.
  - Managing new equipment implementation from the purchase request throughout the release for use (including criticality assessments, qualification testing, SOPs updates, calibration and maintenance set-up, user training)
  - Thorough understanding and testing of the APCA system, leading to major updates of the system
  - Thorough assessment of the RM and FP Modules of NovaLIMS with regards to site processes, leading to major updates of the modules

• Enterprise System Parners (Ireland) - Ingénieur Validation des Systèmes Informatisés

  2007 - 2008 Enterprise System Partners is a consultancy and contracting company specialised in the Pharmaceutical and the Medical Devices industries. Their range of competencies covers feasibility studies, engineering, project management and validation. As a contractor, I was involved in validation projects on ESP’s customers’ sites, becoming a member of the site’s project team. Below are the details of the projects I took part in, as well as my duties and achievements:
  
  Nov 2007-Oct 2008: Wyeth Medica Ireland (Newbridge, co. Kildare, Ireland – Tabletting plant)
   Qualification of the implementation of Electronic Batch Records (PMX Propack Data) for 2 new products: OQ, Integration OQ and PQ, trace matrix, Non Conformances investigation and follow-up
   Change control preparation and execution for the roll-out of Weigh and Dispense module of PMX Propack Data
   Assistance in various validation tasks: audit preparation (FDA, Irish Medecine Board), Periodic Reviews, Documentation Control
  Main achievements:
  - Thorough understanding of the EBR (Electronic Batch Record) Module of PMX Propack Data
  - Implementing a flexible documentation strategy (OQ protocols and test scripts) so as to allow the incorporation of frequent design changes, without requiring cumbersome documentation updates and however insuring the consistency of the whole validation file
  - Addressing a lot of very technical Non Conformances in a short time, therefore not compromising the dead line of the release of the system
  
  Oct 2007: Depuy Ireland Medical Devices - Johnson&Johnson (Ringaskiddy, co. Cork, Ireland):
  Short-term contract to provide urgent assistance to the Equipment Validation manager during a relocation of existing manufacturing equipments:
   Qualification of the relocation of the equipments (spindles, lathes, polishers..) of a tibial tray shop floor: IQ and OQ – writing and execution
  
  Main achievements:
  - Getting familiar very quickly with a new topic such as equipment qualification by applying my knowledge of computer systems validation to identify the deliverables required
  - Hands-on experience when executing the IQs and OQs on the various equipments
  
  Jan 2007 -Sep 2007: Centocor Biologics Ireland - Johnson&Johnson (Ringaskiddy, Ireland - Biomedicines):
  I was responsible for the validation of the implementation of SAP R/3 on a new site in the process of being built: roll-out of existing corporate functionalities as well as any new site-specific functionality
   Coordination between CBIL QA department and the SAP team: choice of the validation approach, and completion of the validation activities
   Validation of SAP R/3 v4.7 SD, QM, WM, PP-PI and MM (purchasing) modules, as well as some Radio-Frequency SAP-based transactions for the warehouse and manufacturing areas.
   Training delivered to business end-users on qualification test scripts : creation and execution
  
  Main achievements:
  - Implementation of a site specific Risks Analysis procedure being compliant both with US Corporate standards and local Irish medicines Board requirements (more demanding)
  - Upgrading the Corporate Qualification Testing Strategy by convincing the Corporate Validation Managers of the need for failure testing
  - Providing CBIL QA Department with a full set of validation deliverables ready for the coming Irish Medicines Board inspection
  - Getting trained to become a trainer (“train the trainer program”)

• CVO-EUROPE - Ingénieur Validation des Systèmes Informatisés

  LYON 2004 - 2006 Cyberconseil is a medium-size consulting company (around 120 consultants) specialized in the pharmaceutical, life sciences and medical devices sectors. Their range of expertise covers engineering and validation in various fields such as manufacturing and laboratory equipments, computer systems, utilities and premises. I worked for them as a computer systems validation consultant, always on the customers’ sites, either with other consultants or on my own. Below are the details of the projects I was involved in, as well as my duties and achievements:
  
  Jan 2006–Dec 2006 Laboratoire Pierre Fabre (Gaillac, France – Plant Extraction, Cytotoxic Active Ingredients):
   Validation of the upgrade of SAP (4.6 C -> mySap ERP Edition 2004) : non regression of existing modules (MM, PP-PI)
   Validation of the implementation of EZCHrom Elite (HPLC and GPC – chromatography network and application)
   Validation of the implementation of TESTO (Temperature monitoring application)
   Validation of the implementation of QALITEL Formation (training management application)
   Validation of the implementation of SAP R/3 QM mySAP ERP Edition 2004 to replace current system in place (mainly paper-based)
   Preparation of an FDA audit, participation in mock audits
  
  Main achievements:
  - I had full delegation from the site’s validation manager for the Computer Systems Validation, therefore I was able to make decisions myself regarding the validation plans and validation approach (as opposed to the regular role of a consultant of giving advice and recommendations without making final decisions)
  - Managing the validation of several projects simultaneously
  - Training the validation technician and the validation trainee
  - Having one direct report (validation technician)
  - Coping with very conservative work methods and staff mentality when trying to put in place new systems
  
  May 2005 -Dec 2005 GSK Biologicals (Wavre, Belgium - Vaccines):
  I joined the site’s validation team to perform operational activities for the validation of various SAP projects, mainly with QM and PM modules of SAP R/3 4.7 (implementations and change management). I also assisted the Validation Manager during corporate audits and one FDA audit.
  Main achievements:
  - Applying the site’s validation procedures which were very complete, precise and the guarantee for a very high-quality validation job
  - Coping with strong-tempered IT project managers
  - First experience of an FDA audit
  
  Nov 2004-April 2005: UCB Pharma (Braine L alleud, Belgium – Tabletting Plant)
   Validation of the implementation of SAP R/3 v4.7 PP-PI and MM (purchasing) modules
   Validation of the interfaces of SAP R/3 with integrated applications
   Validation of the non regression of existing modules: SD, MM (stocks)
   Qualification of data conversion and data migration
  
  Main achievements:
  - Give guidance to the Validation Project Manager in terms of SAP validation
  - Managing the whole testing execution (team of 15 testers to coordinate)
  - Implementing a strategy for the qualification of data conversion and migration
  
  Feb 2005 and Apr 2005: UCB Pharma / Celltech (Rochester, NY, USA – R&D) :
   Qualification of the transfer of the static and transactional data of the modules PP-PI, PM, MM (SAP Rochester -> SAP Atlanta)
   Validation of the mutualisation of Rochester and Atlanta servers: non regression of modules PP-PI, MM and PM, and of the interfaces
  
  Main achievements:
  - Managing a team of 3 testers to carry out a significant load of testing in a very short timeframe
  

• Assystem - Ingénieur Validation des Systèmes Informatisés

  Courbevoie 2003 - 2004 Assystem is an engineering consulting company. One of their divisions covers the Life Sciences sector, and they offer consulting services in engineering and validation, covering various fields such as premises and utilities, computer systems, and equipments. I worked for them as a Junior Computer Systems Validation consultant, starting my career in the pharmaceutical industry. Below are details of the projects I took part in, as well as my duties and achievements:
  
  Sep 2004: Merial (Lyon, France – Veterinary Medicines)
  Short-term position to assist in the IQ and OQ testing (co-execution) of a temperature monitoring computerized system (Chessel)
  Main achievements:
  - Hands-on experience on a new computerized system through qualification testing
  
  July 2004: Genpharma (El Jadida, Morocco – Tabletting Plant)
  Short-term position to assist in the qualification of an HVAC for grade D areas: IQ, OQ and PQ writing and execution, deviations handling and qualification reports.
  Main achievements:
  - Working with an expert in utilities, I learnt about all qualification testing required on HVACs
  - Hands-on experience on a new field such as utilities qualification through qualification testing
  
  Oct 2003 – Jun 2004: Laboratoires Fournier (Dijon, France – Tablets, Syrups and Capsules):
   Validation of the implementation of SAP R/3 4.6c QM
   Validation of the non regression of existing module MM and of the interfaces
  
  Main achievements:
  - Performing risks analysis based on the regulations
  - Getting familiar with the complexity of the QM module of SAP R/3
  
  Jan 2003 – Oct 2003: Astrazeneca (Dunkerque, France – Tablets and Aerosols):
  Validation of the SAP R/3 4.6c PP-PI module within the framework of a multi-sites (Dunkerque, Reims, Monts) implementation of SAP R/3
  Main achievements:
  - Learning the Validation Cycle as directed in the regulations and the GAMP
  - Participating in implementing a multi-site validation documentation
  

Formations

• INSA (Lyon)

  Lyon 1999 - 2002 Ingénieur - Master of Sciences
  
  Gestion de production, logistique, supply chain, gestion de projets industriels

Réseau

• Anne Marie RONAYNE

• Christine BELLIN

• Ilies GHEDHAB

• Ilies SALHI

• Laurent FLIPO

• Lou KROLIKOWSKI

• Pascal DAUMERIES

• Pierre-Francois SAMBRONI

• Thami IDGOUAHMANE