PAGNIEZ Martial

+33 683242931 cell phone

mp1049b2a@westpost.net
Summary:
After 10 years experience in Software Engineering and 5 years experience in Soft
ware Quality Engineering in military and avionic project, received a Masteras De
gree in Software Engineering related to ERP Systems on Production Management. O
ver 15 years as a Computer Systems Validation Consultant and MES Consultant (SAP
MM/PP-PI, Rockwell, Werum systems) for the major pharmaceutical companies in Eu
rope and USA.
Professional Experience:
BD Grenoble Project Manager
April 2010
In charge of defining budget for BMS (Building Management System) revamping
Genzyme France MES consultant
March 2009 March 2010
In charge of URS and workshop to deploy MES PASX Werum and Warehouse Management
System.
Support and train end users.
Warehouse management system deployment:
a Warehouse mapping: storage location, storage bin
a Interface with ERP mfg/pro
a Material Management activities:
o Setup material master data such as material type, statuses and expiry date cal
culation, storage location.
o Draw up business procedure such as raw material purchasing, goods receipt, mat
erial transfer, goods issue and Inventory management.
o Configure business scenarios and perform test (data test creation)
o Draw up training material
o Train end users.
a Setup terminals, PDA scanners and printer labels.
a Perform IQ and SAT tests of business flow such as good receipt, good issues, g
ood movementsa
GE healthcare BUC France Global IT Quality Coach
April 2008 a"Dec 2008
a Objectives:
o Qualify Validation Manager for EMEA.
o Perform training on CSV procedure.
o Provide guidance to validation team and functional team.
o Review validation documents for the major applications.
o Ensure audit readiness.
o Support FDA mock inspection.
Wyeth Ireland MES Consultant
Jan 2006 until Dec 2007
Major achievement: Implementation of Electronic Batch Record based on PMX of Pro
pack-Data interfaced with SAP MM/PP-PI, PI-Sheets and automation through OPC Ser
ver
Activities:
a Maintain Material Master data for Compression, Solution Prep and Coating opera
tions
a Maintain SAP recipe and PI-sheet, BOM and material statuses, Process order and
Batch record.
a Setup QM In Process Control
a Develop EBR for Compression, Solution Preparation and Coating operation, from
Recipe, operation to Process Order execution.
a Develop training material.
a Support MES team for compliance issues and validation activities.
IBM Israel for Perrigo Pharma Company
Nov 2005- Dec 2005
a Train and coach IBM consultants in Best Practices for pharma industry (MM/PP-P
I,PI-Sheets and QM) for Procure to Pay and Make to Stock processes including Ba
tch Management integrated with QM
a Prepare work plan for blueprint activities.
UCB Pharma (Harvey Nash) Belgium
Compliance Consultant
Jan 2004 -October 2005
a Review all validation documents, risk assessment, validation plan, test sheet
execution and report, ensure audit readiness.
a Support and coach SAP team to capture and verify business requirements, to spe
cify business processes and to validate them on risk based approach mainly on MM
/PP-PI/WM/QM modules
a Test Marshall in Rochester USA for SAP testing (OQ and data migration) for MM/
WM/PP-P, PI-Sheets integrated with QM processes such as Material Management pro
cesses (inventory & warehouse) Purchase to Pay, Supply Chain Replenishment and O
rder Fulfillment.
a Project Framework Trainer: Project Management, Project execution and Validatio
n (System Blueprint, System Testing)

Merck (MSD) France

Nov 2002 -Nov 2003
Project Manager for implementation and validation of Electronic Batch Record in
manufacturing area (MES: PMX of Propack-Data), cGMP and 21 CFR Part 11 complian
ce.
a Review of all documentation, manage meeting with related end users, manage the
planning and supervise all validation activities (IQ, OQ, PQ).
Watson Laboratories California (Washington Group)
July -Oct 2002
Computer System Validation Consultant
a Laboratory operation and R&D validation of computer with instrument HPLC, GC/G
CMS, FTIR, Vankel dissolution system, electronic record on GMP server.
Sanofi Synthelabo Research France
June 2002
a Trainer on 21 CFR Part 11: "The keys interpretation and assessment questionnai
re": The attendees were able to assess all computerized system according to the
questionnaire based on 21 CFR Part 11 and Sanofi policies.

Watson Laboratories California (Washington Group)

Aug-2001 - May 2002
Computer System Validation Consultant
a SAP PM/MM validation, data migration verification
a Implementation and validation of Laboratory Information System (SLIM and SLIMS
TAT+ of H&A Scientific) for Stability Department including:
- User Requirement, System Specification, Risk assessment, Traceability Matrix
- SOP: System Administration, backup and recovery,
- IQ, OP, PQ protocol,
- Final report.
Hewlett Packard France
Feb a"July 2001
a Integration and validation for a new MES for PC assembly interfaced with SAP M
M and WM from customer order, picking area, assembly and packaging lines to deli
very finish goods.
a Maintain Material Master Data, BOM/Routing, Process order.
Pfizer, BMS France
2001 (3 weeks)
a Perform GMP audit and specify how to implement Electronic Batch Record integra
ted with legacy systems SAP MM, WM and POMS (dispensary system).
a Analyze the major GMP processes and their related documents and records:
Purchase Order, material receipt, status management, inventory management, Requi
sitions Order, Transfer Order, dispensing management, material consumption.
CyberConseil Lyon France Consultancy Company
1996 - 2000:
Computer System Validation Consultant
Expertise area:
- ERP :( Material Master Data, Master Recipe, Material Status) Protean (Marcam),
mfg/pro (QAD), SAP (MM WM PP-PI) with POMS (dispensary system), end user traini
ng in production and material management
- LIMS (SLIM), Building Management System, Clean Room Monitoring
- DCS Fisher, ABB, PLC Siemens, SCADA Intouch, FIX ...
- Lab instrument HPLC, GC/GCMS, FTIR, Dissolution system
- Regulation and Standards:
-cGMP 21 CFR 210/211, GCP, GLP, 21CFR11 assessment and remediation
-IEEE 830-1998 (Software Requirements Specifications), SPICE (ISO/CEI 15504).
-GAMP4
- Develop methodology of system engineering and computerized production system (
Development of Template such as URS, SRS and functional system)
- Develop validation strategy based on risk analysis and traceability matrix
- Perform all validation activities:
- Generate Validation Master Plan and Validation plan,
- Perform risk analysis and appraise of advance acceptance criteria,
- Draw up SOPs for end user, maintenance,
- Manage Traceability Matrix,
- Draw up all protocol: IQ, OQ, PQ,
- Supervise the execution of all qualifications,
- Manage Non conformity and related changes with suppliers,
- Write the final report.
List of references:
ASP (groupe AstraZnca), Aventis Pasteur/Pasteur Mrieux Connaught, Bayer Pharma,
Barriquand Striflow, Beaufour Ipsen Industrie Clinique, BioMrieux, Chimex, Ethyp
harm, Hoechst Marion Roussel, Lilly France, LaOral, Marion Merrell Bourgoin, Par
ke-Davis, Pharmacie Centrale des Armes, Pfizer, Piston de Colmar, Rhodia, Rhne-P
oulenc Biochimie, Rhne-Poulenc Chimie, Rhne-Poulenc Industrialisation / CRIT, Rh
ne-Poulenc Rorer, Roquette Fr*res, Sanofi-Synthlabo, Sanofi Winthrop, Silicom, S
olvay Peptisyntha, SkyePharma.
1989-1995 Focal Groupe OUROUMOFF : Software House
- Project manager especially in critical projects: aeronautic, military
- Quality Assurance Manager: IS0 9001
1984-1989 Elect Industrie Engineering company
- Project management especially in automation
1981-1984 CORECI process control and instrument Manufacturer
- Management Studies in Advance Process Control in R&D
1976-1981 ELF FRANCE - Refinery
- Maintenance Management
Education and Training:
2007 May 5 days training course SCM340 Process Manufacturing
2002 Nov 5 days training on MES of Propack-Data Germany
2002 Jan SAP Academy France MM Intensive course 5 weeks:
MM Processes, Procurement / Cross Functional Customizing, Materials Planning, In
ventory Management / Physical Inventory / Cross Functional Customizing, Valuatio
n and Account Determination, Invoice Verification, Classification & related area
s in MM / Batch Management, ASAP, IMG / Cross Functional Customizing
2000 Business English course: Eurocentres Business Institute London
1996 Advanced Diploma in science: (DESS) Software/Image/Production Option Enterp
rise Resource Planning: University of Lyon
1980-1989 Certificates: Mathematics, Software Engineering, and Numerical Analysi
s: CNAM Lyon
1975 BTS Automation and instrumentation AFPA Paris