Request Expert

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.