Sr. Director Process Facilities Engineering & GMP Compliance

PBE Expert Inc, is a Leading Canadian Consulting Company involved in GPP Cannabis Grow and GMP extraction and purification of Active Pharmaceutical Ingredients (THC, CBD, CBN, CBG, ...) meeting ICH & GMP regulations, involving Certified Health Canada & MAPAQ Experts.PBE Expert Inc, has successfully accomplished several projects and processes, implementing various extraction technologies, such as : Supercritical CO2 (SCFE), Aqueous or an Alcoholic Extraction, which require the design and control of Explosive Environments that comply with sanitary design regulatory requirements CGMP and related standards ISO-22000 and ATEX, NFPA, in Canada, USA (FDA), in Europe (EMA), as well as North Africa regulations.https://pbe-expert.com/wp-content/uploads/Cannabuy-SERVICES_ENG-3.pnghttps://pbe-expert.com/en/sectors/cannabis-en/GMP Cannabis SME & CPMT Training Company Agreement #0059104GPP CANNABIS & GMP Process, Cleanrooms, Facility & Building Engineering HVAC, Cleanrooms, CO2 Supercritical Extraction & Purification, Validation, PAIC.+1. 514-616-2692 | O.+1.450-600-0790 x 253http://goo.gl/5XH2hK | http://goo.gl/S8MgdW | http://goo.gl/pVZBV1We Process, Build, Engineer

PBE, Pharma Bio Expert Inc., is a leading consulting company providing Independent c-GMP Audit & Review, CAPA, RAPA, GAPA of (EPCMV) Engineering & Project Management Services dedicated to Pharmaceutical, Biotech, Medical Devices, Labs, Hospitals, pharmacies, to meet FDA, EMA, Health Canada & worldwide good manufacturing practices.Dr. Aziz Chraibi, PEng., is PBE's Founder. He is a Leader Pharma Biotech Expert performing independent c-GMP audits and regulations compliance inspections of bio-pharmaceutical labs & facilities.He is a Senior Bio-Pharmaceutical Consultant, acquired more than 26 years experience in BioPharma industries & Consulting, where more than 100 projects were successfully completed.(http://pharmabioeng.com/index.php?page=projects)PBE, Pharma Bio Expert Inc. provides the following services:Independent Compliance Review & Audit (c-GMP, ISO14644, ASME-BPE, HSE): o Sanitary process design & engineering involving ICH Q9 approach (URS, PFD, P&ID, layout) o Classified cleanrooms functional analysis of (A, B, C, D, ISO5-8) o Physical & mechanical segregation requirements o Cross flow & contamination risk analysis o Aseptic design analysis of cleanrooms, equipment, & products o Biological containment facilities design: BSL1@4 o OSD, High potent facilities design: HP1@5, OEL:1@+1000 µg/m3 o Risk management & analysis assessment, & mitigation: DFMEA, ATEX1@3 o CIP, RABS, SIP, layout, design, optimization, cGMP compliance reviewConstruction & project management (EPCMV): o Supervision of delivery, Installation, Commissioning (FAT, SAT) & start-up o On site construction & installation works follow-up & Benchmark o Approval of validation protocols and reports of DQ, IQ, OQ o Management of predictive, preventive & routine maintenance o Management of calibration, sampling & change control programs o cGMP training.

- NHP formulation, development, manufacturing, Co-Packaging, CDMO and sales.- EPCMV, Project Management and Equipment Supply for NHP, Biotechnology, Pharmaceuticals, Horticulture, Aquaponics, Hospitals, Food, Dietary Supplements Industries.https://greentech-canada.com/

The objective of PHARMACIBIS project is to develop a clean, efficient, and durable Medicinal Grade Cannabis industry in Morocco as well as in Canada, Europe, Australia, South Africa, Asia, USA business units, to supply Cannabinoids to the International Pharmaceutical and Well-being markets. This objective includes the following:• To Produce wholesale of non-Psycho-active Raw Cannabinoids Extracts (NPRCE) – Concentrés Bruts non Psyco-actifs de Cannabidoides (CBNPC) - for global pharmaceutical and nutraceutical markets.• To develop the most effective and efficient process of ‘Seed to Extract’ to leverage Morocco’s unique history, political situation, geographical position and land strains among others. • To develop and sale the added value products manufactured in EUGACP and EUGMP Morocco facilities but also in various Business Units, Canada, Europe … LPs (License Producer) Processing facilities as well as NHP & Drugs formulation, development (DMF) and manufacturing compliant to EUGMP / cGMP regulations with worldwide market target, in parallel with local markets. PBE Expert, the consulting company associated with PHARMACIBIS is looking for product development for Asthma, JV, Partnership, License. This respiratory disease is affecting millions of people over the world. We are looking for cannabinoids (CBD) based products that can help relieve inflammatory and allergic respiratory disorders. These products are currently being tested on animals, and some studies have seen the effect of CBD on the receptors for the lung inflammation and airways. PHARMACIBIS is looking to create a join venture with companies having confirmed track records that started testing their products in order to manufacture this product on their already owned PHARMACIBIS facilities in Morocco.NB: in 2021 Morocco legalized only Cannabis for therapeutic & Medical purposes. CBD oils as API, shall include a maximum of 1 % THC.

Pharmaceutical Facilities Engineering, Construction & c-GMP Compliance Design.Pharmaceutical and Biotech Projects ManagementSanitary Process Design & EngineeringClean Utilties, Building Systems & Bio-Pharmaceutical Facilities Design & EngineeringCommissioning, Benchmarking, FAT, SAT, Stratup Several projects were completed involving mainly project management, conceptual design, basic & detailed engineering for facilities, sanitary process equipment, clean utilities, and pharmaceutical and building systems: Sandoz, Pfizer, Novartis, US, Johnson & Johnson Inc., Pillar 5 Pharma, Pharmascience, Galderma, Confab Laboratories, AstraZeneca, Piramal Healthcare, Church & Dwight, Groupe Parima.More details are given at : http://pharmabioeng.com/index.php?page=projects

Lead a multidisciplinary biorefinery research center.Manage all the CRIP biorefinery actvitiesDesign new research fluidized beds setups (1000 C, 20 bars)Oversee more than 20 PhD & Matsers studentsBiotech, Clean Utilities & Chemical engineering lecturer at Ecole Polytechnique de Montreal.

Director of Pharmaceutical, Biotech Engineering & EPCM Project Management, Sanitary Equipments, Process, Building Systems, Utilities, Cleanrooms, Facility Design & Regulation Compliance:* Technical feasibility of projects assessment;* Development of BOD, detailed engineering documents, such as: user requirements, functional design & technical specifications, risk analysis assessment, PFD, P&ID, layouts, equipments, utilities and systems drawings;* Projects Management;* Supply strong analytical skills for estimate analysis, bid evaluations, and change order analysis; * Development of the risk analysis and review plan (Hazop) of the project by applying FMEA/AMDEC assessment and shall support project and site HSE objectives, especially for high potent/BSL facilities and critical equipments, systems & clean utilities; * Benchmarking, commissioning & start-up procedures.http://pharmabioeng.com/index.php?page=projects

 Lead the engineering & project team and develop performance control and measurement methods by identifying project key performance indicators (KPI), resources, deliverables and costs. Develop technical specifications: PFD, P&ID, URS, FRS/FDS, FAT, SAT, Risk Analysis Assessment) according to FMEA, for the following:1. Sanitary process equipment (depyrogenation ovens & steam sterilization autoclaves, SIP/SOP, sterile, ultra filtration & (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 tanks, TCM, heat exchangers/evaporators, condensers, pumps, Clean In Place / CIP, WIP, COP / Washers systems, etc.); 2. Design of the clean rooms (ISO5, 7, 8) and the related building systems (HVAC, HEPA filters, bag in/bag out, chillers, Sterilization In Place / SIP, sanitization, utilities);3. Clean utilities (purified water, WFI, pure and clean steam, compressed air, gas, vacuum);4. Pharmaceutical systems (HVAC, FFU, thermal decontamination & neutralization skids, containment units: barrier isolators, RABS, biological safety, laminar flow cabinets). More than 30 projects were completed involving project management, conceptual design, basic & detailed engineering for facilities, sanitary process equipment, clean utilities, and pharmaceutical and building systems. Fruits & Passion, Laboratoires Renaudin, Aguettant, Becton Dickinson, Becton Dickinson, Ipsen Beaufour, DBI, Idron, Cephalon, Pierre Fabre, Bausch Lomb, Prodoc, Merial, Biovex (CMO), Laborium Inc. (CMO), Biosyntech, Pfizer Laboratoire Denis Giroux, Axcan Pharma Inc,McGill University, BL2 Laboratory, Ferring, OM Pharma, Mayne Pharma, Steris, Labopharm, Neurochem, LAAS- CNRS, Duchesnay, HMR, Biocean, Propharmal, Pangeo, Shire & Draxis, Selgene, Praxilab.http://pharmabioeng.com/index.php?page=projects

Oversee roduction, maintenance & engineering activities.

Manage the engineering design & project expansion for many beet sugar plantsSupervise onsite works & commissioningOversee the production, conditioning & maintenanace activities.