Expert Details

Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering

Expert ID: 730610 Canada

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He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were successfully completed. He will be pleased to be involved in assignment in Biotechnological Process, Facility Building Systems Engineering, Independent Compliance Audit & Review & Project Management. He is also an expert in EU-GMP Medical & Pharmaceutical CANNABIS & CBD, THC, Terpene Oils.

c-GMP, GCP, GLP, GXP Regulations Compliance Review, Audit, & CAPA
Conceptual Design & URS, BOD, PFD, P&ID, Risk Analysis & Mitigation, including:
 Cleanrooms, Facility / HVAC requirements
 Architectural elements definition
 Environmental issues integration&
Sanitary Process / Equipment, Clean Utilities, Bio-Pharmaceutical Systems Design
Process Engineering, & QBD, Equipment Selection
Project Management (Budget, HR, Quality, Performance, Project Cost Estimates, Scheduling)
Construction management and supervision (HSE, Risk Analysis Assessment by means of EMEA, AMDEC, HAZOP, Management & Mitigation)
Commissioning, Benchmarking, FAT, Start-up, SAT, validation IQ/OQ
Predictive, preventive & systemic maintenance
Calibration program management & maintenance
Sampling plan implementation
Change control management and approval

Expert, is a Ph.D. & process engineer, who has more than 21 years’ experience in EPCMV projects involving biotechnology (sugar refining & shortening industries), and
biopharmaceutical facilities design, as well as engineering and construction projects management.

He is skilled in sanitary facility & modular design, pharmaceutical building systems, process equipment and clean utilities in compliance with Canadian and European, as well as FDA
American current Good Manufacturing Practices.

In 2007, he was accepted by Health Canada as a Scientific Expert to lead regulatory compliance audits. Accordingly, he developed skills in design of many facilities involving clean utilities,
pharmaceutical systems dedicated to aseptic manufacturing processes for sterile products highly toxic products (level 3 and 4 according to SafeBridge Standard), biological BSL 2 and 3, oral
solid dosage, bulk chemicals as well.

He has experience in over 50 projects involving facility & construction project management, conceptual design, basic and detailed engineering, commissioning and benchmarking activity follow-ups, FAT, installation, start-up, SAT, qualification, environmental, health & safety and risk management and mitigation measures.

He has also acquired a great deal of international experience, particularly in Europe, North Africa, and North America, as senior project manager, engineer and facility design lead for biopharmaceutical plants.

Project 1: Ipsen Beaufour, Dreux, France, 2005-2007
Expert was the Director, EPCMV Project, Facility Designer & Process Engineer Lead to develop the conceptual design, BOD and detailed engineering (URS,PFD, FDS, RAA, TS, P&ID, Layouts, equipments, clean utilities and pharmaceutical systems specifications, environmental parameters classification for critical rooms specifications and drawings, etc.), construction supervision & commissioning as well as qualification for two facilities :
o A pilot plant production of sterile parenteral of class 3 high potent products.
o A pilot plant production (R&D) of Oral Dosage Form of class 3 & 4 high potent products.
o C-GMP rooms’ specifications, architectural finishes requirements for aseptic design ISO 5 (A) to ISO 8 (D) classified rooms.
o Sanitary c-gpm process equipments, clean utilities and pharmaceutical systems (freeze dryer, CIP, SIP, WFI & purified water productions and loop distributions, pure steam generator, compounding skid and mixing formulation tanks, aseptic filling and barrier isolator, automatic washing machines, sterile filling, laminar flow and biological safety cabinets, drains & plumbing networks, HVAC systems equipped with HEPA bag-In/bag-out filters, Chillers, compressed air system and terminal filtration, instrument & process air & sanitary gas networks, boilers, power backup system, UPS, high shear granulator, compressed tablet machine, coater, wrapping and blistering machine, biological safety cabinets, vacuum system, Torit central deduster and contained system.Project 2: DBI, Idron, France, 2006-2007
He was Senior Process/Design Engineer & Facility Compliance Lead to perform the technical and economical evaluation study for a new CMO pharmaceutical production unit for high potent chemical and BL2 biological products.
o C-GMP rooms specifications, architectural finishes requirements design for BL2 and injectable & sterile parenteral products.
o Technical specifications and cost assessment for process equipments, clean utilities and pharmaceutical systems (similar deliverable scope than Ipsen project) involving wastewater treatment & decontamination (Bio-kill system).Project 3: Laboratoires Renaudin, France, 2008
He was Project Director & Senior Facility Design Engineer to implement new layout, EMA/c-GMP facility compliance review and flux analysis for raw materials, finished products, wastes, personnel.
o Develop the User & Quality Assurance Requirement Specifications (URS) for many AHU deserving classified and clean rooms (B, C, D: ISO6, 7 & 8) performing aseptic & sterile products manufacturing.
o Write the SAT tests sheets for 11 formulation tanks for aseptic product preparation and storage.
Project 4 : Merial, Toulouse, France, 2005
He was the Project Manager & Senior Process Engineer for a new facility design according to ATEX regulation of a new oral solid dosage plant, involving flammable & explosive solvents.
o The design includes URS development document as well as, risk analysis, technical specifications, PFD, P&ID, layout., and involve the followings:
o In Bin Containment totes, for closed transfer system to reduce explosion risk
o High Shear granulator equipped with preparation tanks
o Fluidized bed dryer designed to accommodate explosion risk (Nitrogen blanketing, quick opening & shut-off valve, explosion proof & relief panel designed up to 12 bars).
Project 5 : OM Pharma, Geneva, Switzerland, 2001-2004
He was the Senior Facility Designer & Process Engineer to ensure management for the following :
o BL2 Vaccine facility Layout development and flux analysis of the raw materials, finished products, wastes, personnel.
o Technical specifications development for the following critical equipment:
o Hot air sterilizer, autoclaves for products & for waste decontamination, many compounding skids, mixing, preparation and formulation tanks, fermentation skid, centrifugal separator, washers, CIP, biological safety cabinet, viscous products mixing preparation tanks, ultra filtration units, TFF, Actini‘s Continuous thermal decontamination Bio- kill system of BL2 waste, dedicated HVAC & AHU systems for BL2 areas.

Education

Year Degree Subject Institution
Year: 1990 Degree: PhD Subject: Chemical & Process Engineering Institution: Sciences Faculty, Perpignan University, France
Year: 1986 Degree: Master's Subject: Chemical Engineering Institution: Polytechnic Institute, Toulouse, France
Year: 1986 Degree: BS Subject: Chemical & Process Engineering Institution: ENSIGC - Chemical Engineering College, Toulouse, France
Year: 1984 Degree: BS Subject: Chemistry & Physics Institution: Sciences Faculty, Nancy Vandoeuvre University, France

Work History

Years Employer Title Department Responsibilities
Years: 2011 to 2012 Employer: SNC LAVALIN Title: PROJECT DIRECTOR, SENIOR BIOPHARMA ENGINEER Department: PHARMA Responsibilities: Expert, managed the pharma process team, and was responsible for leading the overall process & engineering projects.

More than 10 projects were succefully managed and the customer's objectives were achieved.

The projects covered mainly the following :

• Sandoz / Novartis, Boucherville, Quebec, Canada, 2011-2012
Project Director & Facility Design Engineer:
o Capital appropriation request (CAR) development for a new 500 Tons centrifugal Chiller & the related Chilled water distribution loops.
o Project management including the development of the project charter, the description of chilled water requirements for the related plants 2 & 3.
o Procurement cost evaluation and comparative study of many Chillers technologies (Scroll, Screw and Centrifugal).
o Installation location definition for the related chillers and condensers components, involving the reduction of the installation and structure costs, the management of budget and tie-in constraints during the August 2012 shutdown.
o Proposal for temporary rental chillers to meet the demand for chilled water in summer 2012.
o Install a suspended ceiling and provide mechanical and electrical services for a packaging area.
o Microbiology laboratory and many warehouses air quality and AHU improvement study.
o Air humidity removal capacity improvement study for many aseptic rooms.
o Detailed engineering (URS, FSDS, integration), commissioning and SAT for particles measuring and remote control systems.
• Pfizer, Montreal, Quebec, Canada, 2011-2012
Project Director & Facility Design Engineer:
o Revamp a warehouse including new ‘Push-back’ rackings and provide detailed engineering, technical specifications and drawings for mechanical, fire protection & electrical, commissioning and works supervision services.
• Pillar 5 Pharma, Ottawa, Ontario, Canada, 2012
Facility Designer & Process Engineer:
o Aseptic Fill & Finish facility upgrade and design compliance review.
o Cost assessment for the facility upgrade.
• Pharmascience, Montreal, Quebec, Canada, 2011
Clean Utilities Design Engineer:
o Review of technical specifications and elaborate URS including performance, operation and installation criteria for two purified water sanitary heat exchangers (ASME – BPE 2009).
• Galderma, Baie d’Urfaie, Quebec, Canada, 2011
Project & Process Manager:
o Feasibility study for installation of a central tank of detergents.
o Feasibility study to increase Steris washer capacity.
o Conceptual design and cost assessment for facility reduction from 77,000,000 to 14,000,000 capsules/year.
• Confab Laboratories, Saint Hubert, Quebec, Canada, 2011
Project & Process Manager:
o PFD, P&ID, FDS and technical specifications development for a CIP.
• AstraZeneca, Saint-Laurent, Quebec, Canada, 2011
Project Manager:
o Feasibility of revamping and cost assessment study for a cage washer.
• Piramal Healthcare, Laval, Quebec, Canada, 2011
Project Manager:
o Study for Cap/Stopper Seal on Glass Vial containing sterile product.
Years: 2001 to 2008 Employer: Validapro Inc Title: Director, Engineering of Process & Building Systems Department: Engineering Responsibilities: Expert, managed the pharma process team, and was responsible for leading the overall process & engineering EPCMV projects.  Supervise up to 15 engineers and manage over 30 biopharmaceutical projects from $20K to $30M.  Manage EPCMV projects, involving construction, detailed engineering, and procurement, as well as MENVIQ and construction permits request, environmental, health & safety impacts assessment, and risk analysis and mitigation.  Develop performance control and measurement methods by identifying project key performance indicators (KPI), resources, deliverables and costs.  Conduct audits, inspections and evaluations of the regulatory compliance of pharmaceutical and biotechnical facilities based on current regulations and laws such as cGMP, FDA, Health Canada, EMEA, MENVIQ, SST, ISO, ASME BPE 2007 and USP;  Develop technical specifications including PFD, P&ID, URS, FRS/FDS, FAT, SAT, Risk Analysis Assessment) according to FMEA, for the following: o Sanitary process equipment (depyrogenation ovens & steam sterilization autoclaves, SIP/SOP, sterile, ultra filtration and (TFF) tangential filtration flow equipment, centrifuges, fermentation skid, freeze dryers (Lyophilisation), chromatographic columns, fluidized bed dryers, presses & compactors, coaters, printers, mills & blenders, high-shear granulators, reactors, mixers & melting thanks, TCM, heat exchangers/evaporators, condensers, pumps, Clean In Place/CIP, WIP, COP/Washers systems, etc.); o Building systems (HVAC, HEPA filters, bag in/bag out, chillers, process utilities); o Clean utilities (purified water, WFI, pure and clean steam, compressed air, gas, vacuum); o Pharmaceutical systems (chemical & thermal decontamination skids, neutralization and containment units: isolators, biological safety cabinets, laminar flow hoods and chemical fume hoods); More than 30 projects were successfully managed and the customer's objectives were achieved, located mainly in Europe (France & Switzerland), Canada (Quebec), USa (Ohaio), North Africa (Algeria)

Government Experience

Years Agency Role Description
Years: 2009 to 2011 Agency: Ecole Polytechnique de Montreal-Canada Role: Deputy director of Process Engineering Research Center - Biorefinery Description: Manage all the center's activities, Manage more than 20 PhD, Matsters researchersManage two new setups for high temperature up to 1000°C and high pressure up 20 bars gas-solid fluidized bed reactor and a bubbling column operating under 20 bars and 200°C

International Experience

Years Country / Region Summary
Years: 2011 to 2012 Country / Region: Canada / Quebec Summary: Sandoz, Boucherville, Quebec, Canada, 2011-2012 Project Director & Facility Design Engineer:o Capital appropriation request (CAR) development for a new 500 Tons centrifugal Chiller & the related Chilled water distribution loops. o Project management including the development of the project charter, the description of chilled water requirements for the related plants 2 & 3.o Procurement cost evaluation and comparative study of many Chillers technologies (Scroll, Screw and Centrifugal).o Installation location definition for the related chillers and condensers components, involving the reduction of the installation and structure costs, the management of budget and tie-in constraints during the August 2012 shutdown. o Proposal for temporary rental chillers to meet the demand for chilled water in summer 2012. o Install a suspended ceiling and provide mechanical and electrical services for a packaging area.o Microbiology laboratory and many warehouses air quality and AHU improvement study. o Air humidity removal capacity improvement study for many aseptic rooms.o Detailed engineering (URS, FSDS, integration), commissioning and SAT for particles measuring and remote control systems.• Pfizer, Montreal, Quebec, Canada, 2011-2012 Project Director & Facility Design Engineer:o Revamp a warehouse including new ‘Push-back’ rackings and provide detailed engineering, technical specifications and drawings for mechanical, fire protection & electrical, commissioning and works supervision services.• Pillar 5 Pharma, Ottawa, Ontario, Canada, 2012 Facility Designer & Process Engineer:o Aseptic Fill & Finish facility upgrade and design compliance review.o Cost assessment for the facility upgrade.• Pharmascience, Montreal, Quebec, Canada, 2011 Clean Utilities Design Engineer:o Review of technical specifications and elaborate URS including performance, operation and installation criteria for two purified water sanitary heat exchangers (ASME – BPE 2009).• Galderma, Baie d’Urfaie, Quebec, Canada, 2011 Project & Process Manager:o Feasibility study for installation of a central tank of detergents.o Feasibility study to increase Steris washer capacity.o Conceptual design and cost assessment for facility reduction from 77,000,000 to 14,000,000 capsules/year.• Confab Laboratories, Saint Hubert, Quebec, Canada, 2011 Project & Process Manager:o PFD, P&ID, FDS and technical specifications development for a CIP.• AstraZeneca, Saint-Laurent, Quebec, Canada, 2011 Project Manager:o Feasibility of revamping and cost assessment study for a cage washer.• Piramal Healthcare, Laval, Quebec, Canada, 2011 Project Manager:o Study for Cap/Stopper Seal on Glass Vial containing sterile product.
Years: 2003 to 2008 Country / Region: France Summary: Laboratoires Renaudin Project Director & Senior Facility Design Engineer: o Implement new layout, EMA/c-GMP facility compliance review and flux analysis for raw materials, finished products, wastes, personnel. o Develop the User & Quality Assurance Requirement Specifications (URS) for many AHU deserving classified and clean rooms (B, C, D: ISO6, 7 & 8) performing aseptic & sterile products manufacturing. o Write the SAT tests sheets for 11 formulation tanks for aseptic product preparation and storage. • Labopharm, Laval, Quebec, Canada, 2003 Building systems/Facility Designer & Process Engineer: o USP purified water, clean compressed air, HVAC and ISO 8 room’s specifications, engineering and commissioning support according to c-GMP FDA and HPFBI. o Oral solid dosage products facility construction and supervision. • Duchesnay, Laval, Quebec, Canada, 2003 Project Director, Senior Process & Facility Design Engineer: o Develop the basis of design, detailed engineering for a new OSD building construction, including: o URS, technical specifications & drawings for equipments and utilities. o Rooms’ layout and sizes specifications to meet optimal process flow and equipment sizes. o Rooms’ classification performance criteria specifications: temperature, humidity (RH%), pressure cascade, air quality and particle class ISO8, air change rate (ACR), fresh air rate, etc.
Years: 2007 to 2007 Country / Region: Aignan, France, Summary: Pierre FabreProject Director, & Senior Facility Design Engineer:o URS & Conceptual design and layout c-GMP compliance review for :• OSD and sterile parenteral products manufacturing facility• Nico-gel manufacturing and conditioning facility (preparation tanks, formulation tanks, mixing tanks, crystallization and cooking, “temperage, formage”, cooling, conditioning,o c-GMP compliance review of the layout and flux analysis of the raw materials, finished products, wastes, personnel.o Risk analysis assessment following FMEA standard.
Years: 2005 to 2005 Country / Region: Amboise, France Summary: Pfizer Global Manufacturing, 2005Project Director & Senior Process Engineer:o Compliance design review of 2 new autoclaves (equipped with loading & unloading doors) installed in washing area (Aseptic & sterile production).
Years: 2003 to 2004 Country / Region: Switzerland, Lauzanne Summary: FerringSenior Process Engineer:o Develop the URS for sanitary process equipements and for clean & plant utilities regarding to USP 26 and the European pharmacopeias, edition 4th:o Purified water production & loops distribution, clean compressed air systems, nitrogen production and distribution systems, (CIP), sanitary vacuum, 400 kg/h, at 11 bars plant steam boiler.

Career Accomplishments

Associations / Societies
Quebec (Canada) Professional Engineers organization. OIQ n.125184
Licenses / Certifications
P.E.
Professional Appointments
Invited by Powder Technology International Journal
Awards / Recognition
Health Canada Scientific Expert
Many recommendations letters issued from customers (Sterigen, Pillar 5 Pharma, Merial, Aguettant, Laporte Consulting)
Publications and Patents Summary
7 publications were accepted in international scientifics journal & proceedings

Additional Experience

Expert Witness Experience
In 2007, he was accepted by Health Canada as a scientific expert to lead regulatory compliance audits. Accordingly, he developed skills in design of many facilities involving clean utilities, pharmaceutical systems dedicated to aseptic manufacturing processes for sterile products highly toxic products (level 3 and 4 according to SafeBridge Standard), biological BSL 2 and 3, oral solid dosage, bulk chemicals as well.
Training / Seminars
ACADEMIC POSTS
2009-2011 Lecturer and teaching assistant, École Polytechnique de Montréal, for:
 1st year chemical engineering - GCH1110: Process analysis and sustainable development.
 3rd year chemical engineering - GCH3110: Chemical reactor engineering.
AWARDS AND SCOLARSHIPS
1986-1990 Thesis scholarship from the Agence Française de Maîtrise de l’Énergie
1990 Thesis issued for the best 1990’s CNRS thesis award
1990-1991 Postdoctoral scholarship through Elf-Aquitaine company funds

PROFESSIONAL DEVELOPMENT
2008-2012 English immersion courses at Centre L’Impulsion, Laval (intermediate level 2).
Université de Montréal (intermediate level 3).
SNC Lavalin & Berlitz English (Level 4).
ADDITIONAL TRAINING
2011-2012 SNC Lavalin Inc.:
 PMTP ‘Project Management Training Program’
 PMTP : PM-340 Introduction to Cost control
 PMTP : PM-360 Introduction to Project Management Software Tools
 PMTP : Conference Legal Affairs: Summary of key-elements in international contracts
 PFGP : PM-601 Construction Management Introduction
 PFGP : PM-501 Project Procurement Introduction
 Lecturer in SLP Lunch & Learn Conferences.
2008-2010 Validapro Biosciences Inc.:
 Engineering and validation: General concepts and IQ/OQ/PQ protocols
 Good Manufacturing Practices (GMP) training
 Design of purified water and HVAC systems for the pharmaceutical industry
 Project management and the use of MS Project
SERVIQ:
 Lean Six Sigma, 5-S, AutoCAD (2007 version)

LECTURER (2011)
 Bioprocess design and validation. École Polytechnique de Montréal.
 Good manufacturing practices applied to Bio-Industries. INRS, Montréal.
Vendor Selection
SANITARY EQUIPMENTS & SYSTEMS SKILLS
OHARA, THOMAS Engineering, ACKLEY : formulation equipments supplier : Coater, Compresion, Compactor & Print)
FINA AQUA, USIFROID FTS systems, KLEE : - Lyophilizators & Freeze dryers;
Lacalene, Skan, ISOTECH Design : - Isolators, Biosafety cabinet for aseptic and steril filling;
IBM: - Clean room design;
DONALDSON & Torit : Central Deduster;
CAMFILL: - HEPA & Bag in / Bag out filters for clean rooms,High potent & BSL areas;
PALL, SARTORIUS, Millipore, US Filter, PEACOCK, CARR, DIATAR : Process Filters, compressed air, phar,maceutical & medical gas, liquid
Marcor, Siemens, Veolia: Purified water & EPPI, Pure steam
Steris, Getinge: Washers, Autoclaves, VHP, Oven & Depyrogenation Tunnel
Steris, ABC Actini, Qualtech: Contaminated waste inactivator
MECART: Modular cleanroom design
Mc Quay,Johnson Control: HVAC systems
ATLAS COPCO, INGERSOLL RAND, COMPAIR : Sanitary Compressed air Production & distribution;
Marketing Experience
2002-2008 Member of Operations Management Committee (SIG), Validapro Inc. & Scientific Advisor for Laborium Inc.
Other Relevant Experience
Project Management
Process & Clean Utilities Design & Detailed engineering
Pharmaceutical systems design
Facilty functional flow analysis
Risk & HSe analysis & mitigation process.

Language Skills

Language Proficiency
English I followed many english courses to improve my speaking:2008-2012 English immersion courses at Centre L’Impulsion, Laval (intermediate level 2).Université de Montréal (intermediate level 3). SNC Lavalin & Berlitz English (Level 4).
French Very fluent. It is my first language
Arabic It is my mother tangue
Spanish I have a basic knowledge

Fields of Expertise

21 CFR Part 11, bio-clean room, biochemical engineering, bioengineering, biofilm, biohazard management, biological process, biological safety, biological waste, biomedical device engineering, bioprocess engineering, bioprocessing, bioreactor, biorefinery, biorheology, biotechnology modeling, biotechnology process engineering, biotechnology scale-up, clean room technology, clean technology, clean-in-place technology, compliance, compliance engineering, engineering, environmental compliance, enzyme technology, FDA medical device regulation, fermentation, Food and Drug Administration, Food and Drug Administration compliance, Food and Drug Administration cosmetic regulation, Food and Drug Administration drug packaging regulation, Food and Drug Administration regulation, food biotechnology, food engineering, food processing, food processing technology, gas regulatory compliance, genetic engineering, Good Manufacturing Practice, industrial biochemical process, industrial biotechnology, industrial fermentation, medical device auditing, medicinal plant, plant biotechnology, plant tissue culture, process engineering, process technology, regulatory compliance auditing, beet sugar processing, biomedical device, clean-in-place, Current Good Manufacturing Practice, demineralizer standard, energy-efficient food processing, engineering standard, equipment sanitizing, European Union's Good Manufacturing Practice, food processing plant, food processing plant design, food product manufacturing, Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice training, hazardous-waste source reduction, aseptic filling, pharmaceutical aseptic filling room, cytotoxic drug, aseptic packaging process, ophthalmic pharmaceutical product, pharmaceutical engineering, pharmaceutical design, pharmaceutical process engineering, pharmaceutical liquid, bulk pharmaceutical chemical manufacturing, pharmaceutical industry, active pharmaceutical ingredient, pharmaceutical filtration, pharmaceutical manufacturing facility auditing, pharmaceutical reactor, pharmaceutical manufacturing, aqueous filtration, injectable pharmaceutical product, pharmaceutical start-up plant, pharmaceutical scale-up, dosage, pharmaceutical operations, OSHA compliance, biotechnology management, alarm management, biodiesel technology, pre-approval inspection, global regulatory procedure, pharmaceutical technology, bulk drug, drug formulation, Food and Drug Administration validation, Generally Recognized As Safe, benchmark, environmental air quality, chromatographic modeling, plant genetic engineering, drug processing, chemical plant-related high-pressure technology, applied biotechnology, chemical safety training, pharmaceutical product formulation, pharmaceutical packaging process, bronchodilator drug, pharmaceutical intermediate, pulp-and-paper industry biotechnology, chemical technology, clean-room management, dairy product safety, biological waste auditing, food processing good manufacturing practice, food ingredient technology, hazard analysis critical control point, drug regulation, pharmaceutical drug, chemical reactor control modeling, oral contraceptive drug, monoclonal antibody, modeling, material substitution process, food technology, dairy processing, chemical reactor scale-up, biotechnology, biomedical device manufacturing, biological modeling

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