Jean-Jacques WEBER

PHARMA
INDUSTRIAL VALIDATION/PRODUCTION
INFORMATIC VALIDATION/PACKAGING
CALCULATION PROCESS/STATS
BIOTECHNOLOGY/IMMUNOLOGY
SOFTMAX PRO EXPERT (C++)
Nom : WEBER Jean-Jacques
Date de naissance 24 Janvier 1955 Expérience : > 30 ans
251, rue Provinciale , 1301, Bierges Fixe : 010/414.997
GSM : 0498/125.269



Competences Summary

Technical competences
• Equipment/Informatic Validation : URS, IQ, OQ, PQ, (P&ID), VSR, PUNCH LIST
• Industrial Washing Machine validation (IQ-OQ-PQ).
• Filters Integrity testing (Sartocheck) (IQ-OQ-PQ).
• Pilot Batches (Vaccines)
• Annual qualification of HVAC and Classified Clean-Room.
• Strobing Control Qualification (4-20 mA); T°, H°, P° and related alarms.
• Lyophilisation Process
• IFIX and Desigo systems (Control & reporting HVAC).
• C3 Soft & hardware validation
• PW-WFI Utilities, Clean Steam (IQ, P&ID, New installation)
• SOFTMAX Pro expert : Complete analysis till final report in C++ (URS, IQ, OQ, PQ).
• Calculation process: Trend analysis, ANOVA, correlation, confidence interval, vaccines stability.log-log, lin-log, 4 parameters with Softmax Pro, Excel
• ELISA : R&D, QC and Validation (immunology & biochemistry)
• Protein Technology : ELISA, Purification, Concentration, Conjugate, Precipitation, Capture (Prot A), Sterile Filtration, SDS-Page, Western Blot, electrophoreses, column filtration.
• Cellular Technology : Cell Culture Techniques (WIL2-NS cells, petri dishes, tissue culture plates & flasks), Density Gradient, Centrifugation and Ultracentrifugatio
Functional competences
• Industrial validation
• Informatic Validation
• Production process
• Laboratories Process Validation
• Biotechnology (immunology & vaccines), protein & peptides

Managerial competences
• Immunologie Lab Supervisor (4 operators,Pfizer Louvain-La-Neuve)
• Assigning Tasks and Defining Practical Objectives for Individuals with yearly reports.
• Laboratory systems & process validation for QA, QC.
• Change forms (SOFTWARE, HARDWARE, analytical process)
• Material, reactives and consummable commands.
• Prioritisation in sampling testing, out of spec treatment (with QA dept)
• Project leader SOFTMAX Pro , Technicians Coaching and Progress Tracking.
• Teaching Skills: Theoretical and Practical Courses (Softmax Pro, C++).
• Lab Technology transfer (from PFIZER-LINCOLN, USA)
• Production planning (ELISA kits : costs, packaging, labeling, balance, inventory & stocks)
• Reporting: Oral and Written (french & english).

Informatic competences
• Microsoft suite :
Word
Excel
Powerpoint
Outlook
• Access
• Visio
• Softmax Pro (Molecular Devices) Expert
• IFIX & DESIGO (HVAC Systems)
Realisations
CTG Consultant at GSK (Wavre) from June 2011 until October 2011
Redaction of RVA (report of Validation Assessment in the QC Biochemistry unit)
• Analytical method deviations
• OOS and OOC (out of specification and out of control)
• Trend on CI (Internal control)
• Trend on vaccine (PQR: product quality revieuw)
• Validation revieuw
• Change control
Biotech Tools (Brussels) from March 2009 until June 2011
R&D Biotechnology, Kits ELISA Production
ELISA kits Production Process (LUPUS detection)
• Raw & intermediate materials (+ commands).
• Semi-finished and finished products.
• Kits packaging & Labeling (+Certificate of Analysis).
• General Production Planning & Production Order.
• Inventory, Balance & Production costs.
R&D
• ELISA R&D, proteins purification process
• QC: on Proteins and peptides analysis for vaccines; sera screening (mouse, rabbit: IgG, IgE-allergy)
• Classic and Inhibition process
• Validation process (Technical & calculation)
• Softmax Pro Calculation
PFIZER Louvain-La-Neuve from March 1993 until December 2007
Validation Specialist (Industrial production/Engeneering) from sept. 2005 until Dec. 2007
• Industrial washing machine for Production dept. (Validated)
• C3 soft/hardware : Printout and labelling automatic control for Packaging dept. (Validated)
• Sartocheck testers (3); Integrity Filter Tester System for

Mes compétences :
ELISA
Validation