What is an Instrumentation Engineer? Instrumentation Engineers are responsible for planning, installing, monitoring and maintaining control systems and machinery within manufacturing environments. They typically work with control processes that use sensors to provide feedback. As a result, that can also have a role in designing and developing customer products that [...]

What is a Biochemist? Biochemists are typically lab-based professionals who study and explore the chemical processes occurring within living things. They are employed across a wide range of industries and within academia. Many Biochemists are employed within research but there are also opportunities in product development and some specialized manufacturing environments. [...]

What is a Microbiologist? A Microbiologist is a scientific professional who studies microorganisms. They play a key role in pharmaceutical or medical device manufacturing by testing to monitor levels of microbial contamination at all stages of the manufacturing process. What is Microbiology? Microbiology is the field of science [...]

Image: GSK What is a Facilities Engineer? Facilities Engineers work in a number of indoor environments including manufacturing facilities, power stations, hospitals, and offices. They can have an extremely broad remit covering the plant maintenance or infrastructure of the building depending on the needs of the company or organization. Areas [...]

A Documentation Specialist is an individual responsible for the writing, distribution, collection, storage, and maintenance of a company’s documentation. In highly regulated industries, these activities are a requirement for regulatory compliance. Some Companies Might Call This Role… Document Controller Documentation Coordinator What is Documentation? Documentation is an [...]

Photo: Sandra Goettisheim, KIT What is a Manufacturing Engineer? A Manufacturing Engineer designs and manages the manufacturing systems for a product. Their main goal is to create the stages of a manufacturing system that turn raw materials such as metal, plastic or wood into a finished (discrete) product in the [...]

CSV Engineers plan, write, implement and review the Computer Systems Validation protocols in place within highly regulated industries. Their work is essential to make sure that all GxP computer-based systems are operating as intended (with documents to prove it) and meet regulatory requirements. Note: Companies also might call this role: CSV Specialist CSV [...]

What is a Calibration Technician? A Calibration Technician is responsible for the calibration, routine inspection, testing, maintenance and repair of instruments, meters, gauges and other testing and measuring equipment. The goal of a Calibration Technician is to ensure the accuracy and precision of the measurements taken using this equipment. According [...]

What is a Production Supervisor? A Production Supervisor is directly responsible for overseeing and organizing the equipment, staff, and processes on a production floor. They will oversee scheduling and routine production activities as well as acting as the first line of support for troubleshooting should problems arise. Some Companies [...]

Computer Systems Validation (CSV) - is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable. The CSV process is used to replace paper and/or handwritten signatures with electronic data in highly regulated environments that impact public health and safety such as the pharmaceutical and medical device industries. These sectors use computer systems to operate and record a range of processes and activities from manufacturing, product testing, distribution, storage, logistics, etc.

What is a Process Engineer? Process Engineers design, implement and optimise chemical and biochemical processes, especially continuous flow ones on an industrial scale to turn raw materials such as oil, natural gas or milk (using heat, pressure or a chemical agent) into an end product (e.g. drugs, cosmetics, gasoline, beer, butter, [...]

Image: The Irish Time What is a Process Technician? Process Technicians work in a process or continuous manufacturing environment and operate equipment, monitor the machinery and document results in strict adherence to protocols. Process manufacturing uses a chemical reaction or blends ingredients continuously or in a batch into a [...]

What is a Project Engineer? A Project Engineer manages technical or engineering projects. They work with stakeholders at all levels, with direct responsibility for budgeting, personnel and project planning and making sure the project is finished on time and on budget. Let’s take a closer look at the details of [...]