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.
ISCO skill level is defined as a function of the complexity and range of tasks and duties to be performed in an occupation. It is measured on a scale from 1 to 4, with 1 the lowest level and 4 the highest, by considering:
the nature of the work performed in an occupation in relation to the characteristic tasks and duties
the level of formal education required for competent performance of the tasks and duties involved and
the amount of informal on-the-job training and/or previous experience in a related occupation required for competent performance of these tasks and duties.
Pharmaceutical engineer is a Skill level 4 occupation.
These occupations require some skills and knowledge of pharmaceutical engineer. They also require other skills and knowledge, but at a higher ISCO skill level, meaning these occupations are accessible from a position of pharmaceutical engineer with a significant experience and/or extensive training.
This knowledge should be acquired through learning to fulfill the role of pharmaceutical engineer.
Good manufacturing practices: Regulatory requirements and Good Manufacturing Practices (GMP) applied in the relevant manufacturing sector. Analytical chemistry: Instruments and methods used to separate, identify and quanitfy matter – the chemical components of natural and artificial materials and solutions. Biological chemistry: Biological chemistry is a medical specialty mentioned in the EU Directive 2005/36/EC. Engineering principles: The engineering elements like functionality, replicability, and costs in relation to the design and how they are applied in the completion of engineering projects. Pharmaceutical drug development: 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. Drug administration regulations: The rules and regulations of the European legislations and of the Food and Drugs Administration regarding clinical trials and drug development. Human physiology: The science that studies the human organs and its interactions and mechanisms. Engineering processes: The systematic approach to the development and maintenance of engineering systems. Pharmaceutical manufacturing quality 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. Pharmaceutical industry: 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. Chemistry: 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.
These skills are necessary for the role of pharmaceutical engineer.
Ensure compliance with environmental legislation: 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. Use a computer: 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. Forecast organisational risks: 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. Ensure compliance with safety legislation: Implement safety programmes to comply with national laws and legislation. Ensure that equipment and processes are compliant with safety regulations. Adjust engineering designs: Adjust designs of products or parts of products so that they meet requirements. Think analytically: Produce thoughts using logic and reasoning in order to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Perform scientific research: Gain, correct or improve knowledge about phenomena by using scientific methods and techniques, based on empirical or measurable observations. Use technical drawing software: Create technical designs and technical drawings using specialised software. Examine engineering principles: Analyse the principles that need to be considered for engineering designs and projects such as functionality, replicability, costs and other principles. Work with chemicals: Handle chemicals and select specific ones for certain processes. Be aware of the reactions which arise from combining them. Write technical reports: Compose technical customer reports understandable for people without technical background. Monitor plant production: Monitor the plant processes set-up and efficiency to ensure the maximum output production levels. Write batch record documentation: Write reports on the manufactured batches history taking into account the raw data, tests performed and compliance to GMP of each batch of product. Apply health and safety standards: Adhere to standards of hygiene and safety established by respective authorities. Assess environmental impact: 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 production input materials: 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). Approve engineering design: Give consent to the finished engineering design to go over to the actual manufacturing and assembly of the product.
This knowledge is sometimes, but not always, required for the role of pharmaceutical engineer. However, mastering this knowledge allows you to have more opportunities for career development.
Pharmaceutical legislation: European and national legal framework for the development, distribution, and use of medicinal products for humans. Types of packaging materials: 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. Chemical preservation: Process of adding chemical compounds to a product, such as food or pharmaceutical products, to prevent decay caused by chemical changes or microbial activity. Software architecture models: 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. Intellectual property law: The regulations that govern the set of rights protecting products of the intellect from unlawful infringement. Industrial software: The selection of software that aids in estimating, managing and scheduling industrial processes such as design, work flow and production improvement. Pharmacovigilance legislation: Regulations used to control and monitor adverse drug reactions at EU level. Pharmacology: Pharmacology is a medical specialty mentioned in the EU Directive 2005/36/EC. Electrical instrumentation engineering: 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. Laboratory techniques: 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. Mechanical engineering: Discipline that applies principles of physics, engineering and materials science to design, analyse, manufacture and maintain mechanical systems. Pharmaceutical chemistry: 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. Toxicology: The negative effects of chemicals on living organisms, their dose and exposure. Packaging engineering: The processes of packaging or protecting products for distribution, storage and sale. Quality assurance methodologies: Quality assurance principles, standard requirements, and the set of processes and activities used for measuring, controlling and ensuring the quality of products and processes. Supply chain management: 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.
These skills and competences are sometimes, but not always, required for the role of pharmaceutical engineer. However, mastering these skills and competences allows you to have more opportunities for career development.
Design pharmaceutical manufacturing systems: 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. Perform chemical experiments: Perform chemical experiments with the aim of testing various products and substances in order to draw conclusions in terms of product viability and replicability. Apply validation engineering: Test the systems used to manufacture pharmaceuticals measuring and analysing the processes to ensure that the products are produced according to specifications. Manage pharmaceutical production facilities construction: 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. Test chemical samples: 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 chemical testing procedures: Manage the procedures to be used in chemical testing by designing them and conducting tests accordingly. Evaluate pharmaceutical manufacturing process: 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. Use chemical analysis equipment: Use the laboratory equipment such as Atomic Absorption equimpent, PH and conductivity meters or salt spray chambre. Provide technical expertise: Provide expert knowledge in a particular field, especially concerning mechanical or scientific subjects, to decision makers, engineers, technical staff or journalists. Develop pharmaceutical drugs: 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. Contribute to registration of pharmaceutical products: 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. Conduct public presentations: Speak in public and interact with those present. Prepare notices, plans, charts, and other information to support the presentation.
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