Mikhail Dvinyaninov

Experience

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  АО "Uralmash"

  Nov 1994 - Nov 1996

  Engineer Design
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  ООО "Coca - Cola Ekaterinburg"

  Nov 1996 - Nov 1999

  Chief Mechanic

  Check of reconstruction of putting of shop under a new line. Operation with contractors. Operation with design entitiess and coordination of their operations with the western producers and suppliers of equipment. Deriving of equipment, set of staff, teaching. Creation of an engineering service and spare parts depot. The deduction of equipment to planning output.

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  ООО "Best Botling", Production and bottling of drinks

  Dec 1999 - Mar 2002

  Chief Mechanic

  Looking up of the suppliers of equipment for a new line on bottling drinks. Conducting of the tender. Negotiating and concluding of the agreements on delivery of equipment. Check of reconstruction of putting of shop under a new line. Operation with contractors. Operation with design entitiess and coordination of their operations with the western producers and suppliers of equipment. Deriving of equipment, set of staff, teaching. Creation of an engineering service and spare parts depot. The deduction of equipment to planning output. Show less

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  PepsiCo

  Mar 2002 - Dec 2002

  The high specialist of Technical Support Division

  Supply by spares both consumabless basic and auxiliary equipment. Looking up of the suppliers, negotiating and concluding of the agreements on delivery. Record-keeping of spares in a warehouse.

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  ООО "SIDEL", Production of blow-machin, for production РЕТ of bottles.

  Mar 2003 - Aug 2006

  Service engineer

  Supply of adjustment, start up, service of deliverable equipment.The concluding of the agreements on service. Supply of repairs and update of delivered equipment. Delivery of spares. Conducting of consultings and teaching of staff of the customer. The equipment is installed on factories of the companies of a Coca - Cola, Pepsi - Cola, Nestle, Bothkarev etc. in Russia, Ukraine, Uzbekistan, Armenia, France

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  ООО Bosch Rexrout

  Aug 2006 - Mar 2011

  Chief of service

  Supply of adjustment, start up, service of deliverable equipment (sterilizers, steam generators, distillers, system of stowage and distribution, preparation system). The concluding of the agreements on service. Supply of repairs and update of delivered equipment. Delivery of spares. The help to the customer in time FAT (Austria, Germany, France). Conducting of consultings and teaching of staff of the customer. Compiling of the passports on pressure vessels. Deriving of the Certificates, Resolutions and opening-up of the documentation in Russian (translation) for the clients. Involvement in the exhibitions. Delivered and start up the equipment at the plants in Moscow, Moscow area, Vladimir area, Kiev (Ukraine), Donetsk (Ukraine), Nesviz (Republic Belorus), Borisov (Republic Belorus), Novosibirsk, Saransk, Penza, Krasnodar, Tver, Izhevsk, Tyumen. Start up equipments on Ukraine (Kiev) and in Syria (Aleppo) is now ended.Participation in the development and checking of User Requirements Specification (URS), for the purchase of new equipment. Show less

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  Takeda Pharmaceuticals Ltd.

  Mar 2011 - Dec 2021

  Qualification and metrology service manager (Technical GMP Manager)

  1. Participation in the project for the construction and launch of a new pharmaceutical enterprise of the company "Takeda" in the city of Yaroslavl. The project is completed, the enterprise is working. Management of processes of qualification and re-qualification work on the process equipment, clean rooms, warehouses (production, warm storage, cold storage), technological systems. Preparation and review of documentation for the (RA, DQ, IQ, OQ, PQ, SAT). Management of processes on the qualification and re-qualification of external organizations, documentation review, the results of the work. Participation in the FAT, preparation / approval of documents for FAT. Management of processes organization of the metrological service and the establishment of metrology laboratory. Management of processes of the activities in the meteorological department companies and perform the necessary work to maintain the meteorological status of the company.2. Project for the production of capsules with API content. The project is in the process of implementation (approximately 90%).3. Project for the new production in tablets. The project is at the initial stage (about 45%).Performed functions during the project, at the moment4. The project on serialization and aggregation, ampoule preparation. Implementation of the project (approximately 90%).5. Functions within the existing production. Show less

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  FSUE Moscow Endocrine Plant

  Dec 2021 - Feb 2024

  Head of the preventive maintenance department

  1. Creation of a system for planning, organizing, carrying out and recording preventive maintenance work.2. Creation of a system for recording, recording, assessing and analyzing breakdowns of equipment and systems.3. Coordination and organization of work during the planned shutdown of the plant in winter and summer, carrying out repair work on equipment and systems.4. Verification and approval of system documentation: - Compressed air (CA); - Prepared water (PW); - Water for injection (WFI); - Pure steam (PS Clean); - Pure steam for HVAC systems (PS for HVAC systems)5. Checking and approval of technical and operational documentation for production equipment.6. Participation in the preparation of the Validation Master Plan.7. Carrying out acceptance and certification of objects and systems.8. Checking and approval of technical documentation for equipment and qualification documentation.9. Development and coordination of documentation for certification of equipment and systems.10. Participation in external and internal audits.11. Participation in the preparation of the Master Dossier of the production site.12. Participation in enterprise modernization projects.13. Organization and acceptance of work by third-party organizations.14. Recruitment of personnel for the department.15. Participation in equipment acceptance. Show less

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  Velpharm-M

  Feb 2024 - Mar 2024

  Deputy Chief Engineer

  1. Control and organization of equipment maintenance, implementation of schedules for preventive maintenance carried out by the department of the chief mechanic, the department of the chief power engineer in accordance with the requirements for the production of medicines, taking into account the requirements and Rules of Good Manufacturing Practice.2. Preparing equipment for operation, including organizing and participating in FAT and SAT tests.3. Implementation of measures to introduce safe equipment and production technologies.4. Monitoring the implementation of the instructions of state supervisory authorities within the established time limits.5. Monitoring the implementation of measures to preserve the life and health of workers in the event of the possibility of emergency situations, incl. to provide first aid to victims.6. Analysis and use in one’s activities of information on scientific and technical achievements in the field of construction of clean rooms, technological and energy equipment.7. Promoting innovation and invention, organizing assistance to innovators and inventors in the design and substantiation of proposals and inventions.8. Participation in carrying out activities to ensure the maintenance of the FGC/QMS of the enterprise in a functioning state, within the framework of their job responsibilities.9. Development of proposals and implementation of activities aimed at improving the FGC/QMS. Show less