Profession 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.

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Personality Type

  • Investigative / Realistic

Knowledge

  • Engineering processes

    The systematic approach to the development and maintenance of engineering systems.

  • 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.

  • 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.

  • Good manufacturing practices

    Regulatory requirements and Good Manufacturing Practices (GMP) applied in the relevant manufacturing sector.

  • 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.

  • Analytical chemistry

    Instruments and methods used to separate, identify and quanitfy matter - the chemical components of natural and artificial materials and solutions.

  • 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.

  • Human physiology

    The science of the mechanical, physical, bioelectrical and biochemical functions of humans, their organs and cells in good health.

  • Biological chemistry

    Biological chemistry is a medical specialty mentioned in the EU Directive 2005/36/EC.

  • 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.

Skills

  • Think analytically

    Produce thoughts using logic and reasoning in order to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

  • Adjust engineering designs

    Adjust designs of products or parts of products so that they meet requirements.

  • Approve engineering design

    Give consent to the finished engineering design to go over to the actual manufacturing and assembly of the product.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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.

  • Perform scientific research

    Gain, correct or improve knowledge about phenomena by using scientific methods and techniques, based on empirical or measurable observations.

  • Apply health and safety standards

    Adhere to standards of hygiene and safety established by respective authorities.

  • Work with chemicals

    Handle chemicals and select specific ones for certain processes. Be aware of the reactions which arise from combining them.

  • 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.

  • Examine engineering principles

    Analyse the principles that need to be considered for engineering designs and projects such as functionality, replicability, costs and other principles.

  • 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.

  • Use technical drawing software

    Create technical designs and technical drawings using specialised software.

  • Write technical reports

    Compose technical customer reports understandable for people without technical background.

Optional knowledge and skills

apply validation engineering quality assurance methodologies pharmacology types of packaging materials supply chain management develop pharmaceutical drugs manage chemical testing procedures pharmaceutical legislation software architecture models perform chemical experiments provide technical expertise chemical preservation packaging engineering laboratory techniques conduct public presentations evaluate pharmaceutical manufacturing process pharmacovigilance legislation electrical instrumentation engineering industrial software contribute to registration of pharmaceutical products test chemical samples pharmaceutical chemistry intellectual property law design pharmaceutical manufacturing systems mechanical engineering use chemical analysis equipment toxicology manage pharmaceutical production facilities construction