A Validation Team Member is a type of validation professional based within an engineering consultancy, not within a pharmaceutical or medical device manufacturing company. People in this role will typically work within a project team on large, capital projects. This type of validation role can bring a higher salary than Validation Technicians as there is often [...]

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 processes, such as blood glucose meters or [...]

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 Biochemistry? Biochemistry is [...]

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 that focuses on the characteristics of microorganisms. This [...]

A Validation Technician works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result. This ensures that the product is consistently of the highest quality. What is Validation? Validation describes the [...]

Facilities engineers work in a number of indoor environments including manufacturing facilities, hospitals, and offices. They can have an extremely broad remit covering the infrastructure of the building, depending on the needs of the company. Areas of direct responsibility might include environmental, health and safety issues, electrical engineering or HVAC (heating, ventilation and air [...]

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 extremely important part of many [...]

Manufacturing Engineers are the individuals responsible for development, design, implementation, and monitoring of equipment, tools, and machinery used in the manufacturing process. Their primary goal is to create the stages of a manufacturing system that ultimately produces a product in the most time-efficient and cost-effective way possible, while always maintaining staff safety and product [...]

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

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 call this role: Electrical and Instrumentation Technician What [...]

A Production Supervisor is the person 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 first-line troubleshooting should problems arise. Some companies might call this role: Process Supervisor, Manufacturing Supervisor What is Production Supervision? [...]

What is Computer Systems Validation? Computer Systems Validation (CSV) is a process used to ensure (and document) that all computer-based systems will produce information or data that meet predefined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. The process is used [...]