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.

Personality Type

• Investigative / Realistic

Knowledge

• 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.

• Human physiology

  The science that studies the human organs and its interactions and mechanisms.

• Good manufacturing practices

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

• 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.

• 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 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.

• 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.

• Analytical chemistry

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

• Engineering processes

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

• Drug administration regulations

  The rules and regulations of the European legislations and of the Food and Drugs Administration regarding clinical trials and drug development.

• Biological chemistry

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

Skills

• 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.

• 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.

• 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.

• Perform scientific research

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

• 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.

• Monitor plant production

  Monitor the plant processes set-up and efficiency to ensure the maximum output production levels.

• Adjust engineering designs

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

• Use technical drawing software

  Create technical designs and technical drawings using specialised software.

• 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.

• Think analytically

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

• Apply health and safety standards

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

• Write technical reports

  Compose technical customer reports understandable for people without technical background.

• Approve engineering design

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

• 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.

• 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).

• 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.

Optional knowledge and skills

Source: Sisyphus ODB