Инженер фармацевтического производства — работа в Финляндии
Pharmaceutical engineers design and develop technologies used in pharmaceutical research and drugs manufacture, advising the pharmaceutical manufacturing plants to maintain and operate those technologies and ensuring the customers` and workers` safety requirements are met. They may also be involved in the conception and design of pharmaceutical manufacturing plants and research centers.
Инженер фармацевтического производства - Какие навыки обязательны?
Monitor activities and perform tasks ensuring compliance with standards involving environmental protection and sustainability, and amend activities in the case of changes in environmental legislation. Ensure that the processes are compliant with environment regulations and best practices.
Utilise computer equipment or digital devices to facilitate quality control, data management, and communication. Follow instructions given by a computer programme, create computer files or documents.
Regulatory requirements and Good Manufacturing Practices (GMP) applied in the relevant manufacturing sector.
Instruments and methods used to separate, identify and quanitfy matter - the chemical components of natural and artificial materials and solutions.
Analyse the operations and actions of a company in order to assess their repercussions, possible risks for the company, and to develop suitable strategies to address these.
Biological chemistry is a medical specialty mentioned in the EU Directive 2005/36/EC.
The engineering elements like functionality, replicability, and costs in relation to the design and how they are applied in the completion of engineering projects.
Implement safety programmes to comply with national laws and legislation. Ensure that equipment and processes are compliant with safety regulations.
Drug manufacturing phases: pre-clinical phase (research and tests on animals), clinical phase (clinical trials on humans) and the sub-phases required to obtain as an end product a pharmaceutical drug.
Adjust designs of products or parts of products so that they meet requirements.
Produce thoughts using logic and reasoning in order to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
The rules and regulations of the European legislations and of the Food and Drugs Administration regarding clinical trials and drug development.
Gain, correct or improve knowledge about phenomena by using scientific methods and techniques, based on empirical or measurable observations.
The science that studies the human organs and its interactions and mechanisms.
Create technical designs and technical drawings using specialised software.
The systematic approach to the development and maintenance of engineering systems.
The quality systems model that apply in pharmaceutical manufacturies. The most common system ensures quality in facilities and equipment system, laboratory controls system, materials system, production system and packaging and labelling system.
Analyse the principles that need to be considered for engineering designs and projects such as functionality, replicability, costs and other principles.
Handle chemicals and select specific ones for certain processes. Be aware of the reactions which arise from combining them.
Compose technical customer reports understandable for people without technical background.
The main stakeholders, companies and procedures in the pharmaceutical industry and the laws and regulations that govern the patenting, testing, safety and marketing of drugs.
Monitor the plant processes set-up and efficiency to ensure the maximum output production levels.
Write reports on the manufactured batches history taking into account the raw data, tests performed and compliance to GMP of each batch of product.
The composition, structure, and properties of substances and the processes and transformations that they undergo; the uses of different chemicals and their interactions, production techniques, risk factors, and disposal methods.
Adhere to standards of hygiene and safety established by respective authorities.
Monitor environmental impacts and carry out assessments in order to identify and to reduce the organisation's environmental risks while taking costs into account.
Test the supplied materials prior to their release into processing, ensuring the results are complying with GMP (Good Manufacturing Practices) and to the suppliers` COA (Certificate of Analysis).
Give consent to the finished engineering design to go over to the actual manufacturing and assembly of the product.
Инженер фармацевтического производства - Какие навыки полезны, но не обязательны?
European and national legal framework for the development, distribution, and use of medicinal products for humans.
Properties of materials that make them suitable for packaging. Conversion of raw materials into packaging materials. Different types of labels and materials used which comply with the correct storage criteria depending on the goods.
Design production control systems which involve all processes from pharmaceutical production process to pharmaceutical stocks with the purpose of providing the correct input for the development of pharmaceutica manufacturing plant software packages.
Process of adding chemical compounds to a product, such as food or pharmaceutical products, to prevent decay caused by chemical changes or microbial activity.
The set of structures and models needed to understand or describe the software system, including the software elements, the relations between them and the properties of both elements and relations.
The regulations that govern the set of rights protecting products of the intellect from unlawful infringement.
The selection of software that aids in estimating, managing and scheduling industrial processes such as design, work flow and production improvement.
Regulations used to control and monitor adverse drug reactions at EU level.
Perform chemical experiments with the aim of testing various products and substances in order to draw conclusions in terms of product viability and replicability.
Pharmacology is a medical specialty mentioned in the EU Directive 2005/36/EC.
Test the systems used to manufacture pharmaceuticals measuring and analysing the processes to ensure that the products are produced according to specifications.
The way in which electrical and instrumentation engineering (E and I engineering) modernises the production infrastructure from design to preparation of execution phase and the execution phase itself followed by the after-sales services, improvements obtain by using the electrical and instrumentation engineering.
Techniques applied in the different fields of natural science in order to obtain experimental data such as gravimetric analysis, gas chromatography, electronic or thermic methods.
Discipline that applies principles of physics, engineering and materials science to design, analyse, manufacture and maintain mechanical systems.
Manage the design and construction of pharmaceutical production facilities making sure the facilities and process validation are according to the planning and conform to FDA and GMP.
Perform the testing procedures on the already prepared chemical samples, by using the necessary equipment and materials. Chemical sample testing involves operations such as pipetting or diluting schemes.
Manage the procedures to be used in chemical testing by designing them and conducting tests accordingly.
The chemical aspects of identification and synthetic alteration of chemical entities as they relate to therapeutic use. The way various chemicals affect biological systems and how they can be integrated in drug development.
Evaluate the ongoing pharmaceutical production process against the latest developments on the market regarding the mixing, compounding and packaging, ensuring the necessary updates are implemented.
The negative effects of chemicals on living organisms, their dose and exposure.
The processes of packaging or protecting products for distribution, storage and sale.
Use the laboratory equipment such as Atomic Absorption equimpent, PH and conductivity meters or salt spray chambre.
Provide expert knowledge in a particular field, especially concerning mechanical or scientific subjects, to decision makers, engineers, technical staff or journalists.
Quality assurance principles, standard requirements, and the set of processes and activities used for measuring, controlling and ensuring the quality of products and processes.
Develop new therapeutic products according to the potential formulas, studies and indications recorded during the research process which involved also collaboration with physicians, biochemists and pharmacologists.
Participate in the registration process that allows the sale and distribution of substances that treat or prevent human and animal diseases or enable medical diagnosis.
The flow of goods in the supply chain, movement and storage of raw materials, work-in-process inventory, and finished goods from point of origin to point of consumption.
Speak in public and interact with those present. Prepare notices, plans, charts, and other information to support the presentation.