Yann WAHL

En résumé

Entreprises

• Baxter International - Project Coordinator - Product Lifecycle Management

  Maurepas 2015 - maintenant Consulting Engineer (agap2) - Company: BAXTER Biosciences in Neuchâtel (Switzerland) - Department: Technical Process Science & Technology Operations - LifeCycle Management for Recombinant:
  
  • Management of Tech Ops Project Portfolio :
  -Collect projects proposal from local Tech Ops teams and insure that adequate informations is provided (business cases, financial, benefits, risks, etc).
  -Prioritize according benefits vs efforts criteria and set which projects are retains for further evaluation and implementation.
  -Update the portfolio project list consolidated from various plants and provide as inputs to Global PM-TT within PSTO.
  -Support consolidation at PM-TT level.
  
  • Lead global & local projects in the recombinant plant network according to the defined matrix – process&manufacturing related.
  
  • Lead the overall design of the process changes and monitor the execution.
  
  • Provide the business case for new projects (process changes) in the area of yield or robustness improvement, risk mitigation, innovation.
  
  • Report out progress on implementation to senior management within the Recombinant Project Review Committee.
  

• Baxter International - Process and Validation Engineer

  Maurepas 2013 - 2014 Consulting Engineer (Agap2) - Company: BAXTER Biosciences in Neuchâtel (Switzerland) - Department: Technical services and process validation.
  
  Activities:
  •Establishment of a validation strategy as part of the submission of a new product. Writing protocols and validation reports.
  •Collaboration with the planning department, the production staff and the analytical laboratory for the elaboration of the sampling and analysis plan.
  •Preparation and follow-up of sampling protocols in collaboration with analytical laboratories and production team. Inter-site management and coordination (Singapore, Thousand Oaks (USA)).
  •Establishment of filter testing at pilot scale in collaboration with ETHZ. Writing of specifications. Simulation of the conditions causing non-compliance in order to evaluate the effectiveness of the filters. Initiative related to the investigation phase of a CAPA.
  •Development of a model (business case) to assess the losses due to the insufficient control of the process parameters. Proposed solutions are part of a process of continuous improvement project.
  •Production and quality services support as a technical expert for the evaluation of the impact (Risk assessment) of non-conformities on the quality of the product.
  •Weekly preparation of SPC (Statistical Process Control) to monitor process parameters and investigate the special root causes behind deviations.
  •Modeling on Super Pro Designer, with the support of production team, of the current production process to assess areas for improvement (Debottlenecking, discard, operating range) and perform simulations in the context of implementation of new solutions / technologies.
  •Validation Report about the robustness and performance of an Immunoaffinity chromatography resin over its lifecycle. Retrospective validation based on historical data and statistical analysis in order to highlight possible cause and effect relationships.

• Baxter International - Process Engineer

  Maurepas 2012 - 2013 Consulting Engineer (Agap2) - Company: BAXTER Biosciences in Neuchâtel (Switzerland) - Department: Technical services
  Baxter, in a process of continuous improvement and enhancing knowledge of the process initiated the QBD (Quality by Design) project whose aim is to overcome the identified gaps but also to document, through reports, the accumulated knowledge:
  Activities:
  •Review of FMEA parameters and criticality reassessment following investigations and new elements of knowledge.
  •Establishment of a " gap remediation plan" to document and formalize all solutions.
  •Capability Study (Statistics) to define " operating ranges " in which the parameters may change
  •Changing interlocks in collaboration with the production staff to reduce waiting time (Hold time) of the product in the operational flow and improve its quality (including viral aspects).
  •In charge of Inter-site alignment between SINGAPORE, Thousand Oaks (USA) and Neuchâtel (SWITZERLAND).
  •Collaboration with the laboratory at pilot scale to conduct studies on the product and obtain new pieces of knowledge.

• Ecole des Mines d'Albi - Apprentice Engineer - Process engineering

  ALBI CT 09 2011 - 2012 Process engineering project within the Ecole des Mines d'Albi-Carmaux:
  Design, dimensioning and implementation of a crystallization process applying supercritical anti-solvent on an active pharmaceutical substance:
  
  • Literature search (Elsevier) on the solubility of the solvent, anti-solvent and the active substance. Determining the impact of a ternary mixture on the solubility of each component.
  • Determination of the thermodynamic model to apply to the simulation (Aspen Plus).
  • Process modelling on Aspen Plus (simulation software) and establishment of all process parameters according to maximum performance (yields) and environmental standards.
  • Evaluation of costs and ROI (Return on Investment)
  • Process implementation with Visio.

• Pharmaster - Apprentice (Sandwich Course) Engineer Validation and Technical Services

  2009 - 2012 Apprentice Engineer – Company: PHARMASTER (SYNERLAB) in Erstein (FRANCE) specialized in the manufacturing and packaging of sterile products:
  
  Validation department:
  • Drafting protocols. Planning, performing validation tests on process and equipment’s (Sterilizer, Pure Steam Generator….).
  • Writing of the associated validation reports.
  • Deviation and non-conformities management.
  • Implementation of sampling and work plans in collaboration with different internal departments.
  • Management of teams and subcontractors as part of my mission.
  
  Technical Services:
  • Defining requirements and drafting URS in the context of new equipment purchasing.
  • Risk and requirements assessment according to internal procedures, GMP and ISO 13485.
  • Validation of plans and PID’s.
  • Review of technical and functional nomenclatures of a new formulation zone (Process zone) in cooperation with our service provider.
  • Accountable for modifying the purified water loop distribution: correction of reverse slopes, modification of water drawing points, chose the type of valves and stainless steel according to pharmaceutical standards. Contractor management and isometric reviewing.
  • Implementation of a stock of critical spare parts and metrology equipment to ensure continuity of the production operations.
  • Reviewing and negotiation of contracts with the suppliers.
  • Train and support staff in the handling of new equipments.

Formations

• Institut Challenge Optimum S.A.

  Genève 2014 - maintenant Green Belt Six Sigmas

• Ecoles Des Mines D'Albi-Carmaux

  Albi 2009 - 2012 Generalist Engineering (Master degree)
  
  Process Engineering, Production and Supply Management, Flow simulation, Processes Modelling, Continuous improvement (Lean, 5S, VSM).

• IUT Louis Pasteur

  Schiltigheim 2007 - 2009 DUT - Advanced technician’s certificate in Bioengineering specialized in Food Industry
  
  Microbiology, Analytical Chemistry, Process/Food Engineering, Quality

Réseau

• Alain STOLL

• Alexandre LAMBERT

• Caroline BOUVET

• Cécile DOMMANGET GUILLIN

• Jérémie ALQUIER

• Mathieu LEGLISE

• Olivier LECOQ

• Pierre-Germain MARLIER

• Séverine DUMUR

• Théo BOUFFARD