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What is an Instrumentation Engineer and what do they do?

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 utilize such [...]

What is a Biochemist and what to they do?

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 and what do they do?

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 [...]

What is a Documentation Specialist?

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 [...]

What is a Manufacturing Engineer?

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 [...]

What is a CSV Specialist?

CSV Specialists 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: Some companies might call this role: CSV Engineer [...]

What is a Calibration Technician and what do they do?

What is a Calibration Technician? Calibration Technicians work across most manufacturing industries. They are responsible for the routine inspection, testing, maintenance and repair of instruments and manufacturing equipment. The purpose of the Calibration Technician role is to ensure the accuracy of the measurements taken using this equipment. Some Companies Might [...]

What is Computer System Validation (CSV) in the Pharmaceutical Industry?

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 Project Engineer?

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 the [...]