What skills does a pharmaceutical engineer need?

A pharmaceutical engineer needs 26 essential skills including good manufacturing practices, analytical chemistry, biological chemistry, engineering principles, pharmaceutical drug development. Core competencies include .

Will AI replace pharmaceutical engineer jobs?

The AI disruption score for pharmaceutical engineer is 71/100 (high risk). Some tasks may be automated but the role will evolve rather than disappear entirely.

Science & ResearchScience and engineering professionalsISCO 2145

pharmaceutical engineer

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.

European Skills Framework

Skills and knowledge areas required for this occupation based on European classification.

Essential (26)

good manufacturing practicesgood manufacturing practicesRegulatory requirements and Good Manufacturing Practices (GMP) applied in the relevant manufacturing sector.analytical chemistryanalytical chemistryInstruments and methods used to separate, identify and quantify matter-the chemical components of natural and artificial materials and solutions.biological chemistrybiological chemistryBiological chemistry is a medical specialty mentioned in the EU Directive 2005/36/EC.engineering principlesengineering principlesThe 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 developmentpharmaceutical drug developmentDrug 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 regulationsdrug administration regulationsThe rules and regulations of the European legislations and of the Food and Drugs Administration regarding clinical trials and drug development.human physiologyhuman physiologyThe science that studies the human organs and its interactions and mechanisms.pharmaceutical manufacturing quality systemspharmaceutical manufacturing quality systemsThe quality systems model that apply in pharmaceutical manufacturies. The most common system ensures quality in facilities and equipment system, laboratory controls system, materials system, productio...pharmaceutical industrypharmaceutical industryThe main stakeholders, companies and procedures in the pharmaceutical industry and the laws and regulations that govern the patenting, testing, safety and marketing of drugs.chemistrychemistryThe 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 fa...industrial research and developmentindustrial research and developmentThe set of activities that companies carry out to do industrial innovation and introduce new engineering products and services or new industrial production processes.ensure compliance with environmental legislationensure compliance with environmental legislationMonitor activities and perform tasks ensuring compliance with standards involving environmental protection and sustainability, and amend activities in the case of changes in environmental legislation....forecast organisational risksforecast organisational risksAnalyse 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 legislationensure compliance with safety legislationImplement safety programmes to comply with national laws and legislation. Ensure that equipment and processes are compliant with safety regulations.adjust engineering designsadjust engineering designsAdjust designs of products or parts of products so that they meet requirements.perform scientific researchperform scientific researchGain, correct or improve knowledge about phenomena by using scientific methods and techniques, based on empirical or measurable observations.use technical drawing softwareuse technical drawing softwareCreate technical designs and technical drawings using specialised software.examine engineering principlesexamine engineering principlesAnalyse the principles that need to be considered for engineering designs and projects such as functionality, replicability, costs and other principles.work with chemicalswork with chemicalsHandle chemicals and select specific ones for certain processes. Be aware of the reactions which arise from combining them.write technical reportswrite technical reportsCompose technical customer reports understandable for people without technical background.monitor plant productionmonitor plant productionMonitor plant processes and efficiency set-up to ensure the maximum output of production levels.write batch record documentationwrite batch record documentationWrite reports on the manufactured batches history taking into account the raw data, tests performed and compliance to Good Manufacturing Practices (GMP) of each batch of product.apply health and safety standardsapply health and safety standardsAdhere to standards of hygiene and safety established by respective authorities.assess environmental impactassess environmental impactMonitor 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 materialstest production input materialsTest 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 designapprove engineering designGive consent to the finished engineering design to go over to the actual manufacturing and assembly of the product.

Optional (32)

pharmaceutical legislationpharmaceutical legislationEuropean and national legal framework for the development, distribution, and use of medicinal products for humans.types of packaging materialstypes of packaging materialsProperties 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 ...chemical preservationchemical preservationProcess 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 modelssoftware architecture modelsThe 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 lawintellectual property lawThe regulations that govern the set of rights protecting products of the intellect from unlawful infringement.industrial softwareindustrial softwareThe selection of software that aids in estimating, managing and scheduling industrial processes such as design, work flow and production improvement.pharmacovigilance legislationpharmacovigilance legislationRegulations used to control and monitor adverse drug reactions at EU level.pharmacologypharmacologyPharmacology is a medical specialty mentioned in the EU Directive 2005/36/EC.electrical instrumentation engineeringelectrical instrumentation engineeringThe 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 ...scientific literaturescientific literatureThe medium of informing the scientific community, including academic researchers, about the results of scientific research. It constitutes a permanent and cumulative collection of all the findings of ...laboratory techniqueslaboratory techniquesTechniques 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 engineeringmechanical engineeringDiscipline that applies principles of physics, engineering and materials science to design, analyse, manufacture and maintain mechanical systems.pharmaceutical chemistrypharmaceutical chemistryThe 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 integrat...toxicologytoxicologyThe negative effects of chemicals on living organisms, their dose and exposure.packaging engineeringpackaging engineeringThe processes of packaging or protecting products for distribution, storage and sale.quality assurance methodologiesquality assurance methodologiesQuality assurance principles, standard requirements, and the set of processes and activities used for measuring, controlling and ensuring the quality of products and processes.computational chemistrycomputational chemistryThe branch of chemistry that aims at addressing complex chemical problems through computer simulations.supply chain managementsupply chain managementThe 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.design pharmaceutical manufacturing systemsdesign pharmaceutical manufacturing systemsDesign 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 pha...improve safety of medicinesimprove safety of medicinesImprove the efficacy and safety of medication by promoting evidence-based medicine, development of guidelines and care protocols.perform chemical experimentsperform chemical experimentsPerform chemical experiments with the aim of testing various products and substances in order to draw conclusions in terms of product viability and replicability.test pharmaceutical processtest pharmaceutical processTest the systems used to manufacture pharmaceuticals measuring and analysing the processes to ensure that the products are produced according to specifications.analyse medication's impact on brainanalyse medication's impact on brainConsult on pharmaceutical drug trials that might impact the central nervous system.manage pharmaceutical production facilities constructionmanage pharmaceutical production facilities constructionManage 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 samplestest chemical samplesPerform 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 schem...manage chemical testing proceduresmanage chemical testing proceduresManage the procedures to be used in chemical testing by designing them and conducting tests accordingly.evaluate pharmaceutical manufacturing processevaluate pharmaceutical manufacturing processEvaluate 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 equipmentuse chemical analysis equipmentUse the laboratory equipment such as Atomic Absorption equimpent, PH and conductivity meters or salt spray chambre.provide technical expertiseprovide technical expertiseProvide expert knowledge in a particular field, especially concerning mechanical or scientific subjects, to decision makers, engineers, technical staff or journalists.develop pharmaceutical drugsdevelop pharmaceutical drugsDevelop new therapeutic products according to the potential formulas, studies and indications recorded during the research process which involved also collaboration with physicians, biochemists and ph...contribute to registration of pharmaceutical productscontribute to registration of pharmaceutical productsParticipate 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 presentationsconduct public presentationsSpeak in public and interact with those present. Prepare notices, plans, charts, and other information to support the presentation.