Departments Before we consider specific roles, we should first discuss the departments typically found within a pharmaceutical manufacturing company: Production (Manufacturing) - operate the machinery and systems that actually produce the pharmaceutical product. (Approx 50% of total staff) Validation - assess and document all equipment and processes to ensure that an action, process or system leads [...]
What is a Manufacturing Technician?
Manufacturing Technicians work in a discrete manufacturing environment, run and maintain factory equipment and assembly processes, monitor and check the product quality and document results in strict adherence to protocols. Manufacturing Technician's role is pretty broad in nature and they often use a blend of technical and mechanical skills to do their job. They [...]
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 processes, such as blood glucose meters or [...]
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 Biochemistry? Biochemistry is [...]
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 that focuses on the characteristics of microorganisms. This [...]
What is a Facilities Engineer?
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 [...]
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 extremely important part [...]
What is a Manufacturing Engineer?
What is a Manufacturing Engineer? Manufacturing Engineers design and operate the manufacturing systems for a product. They choose the best technologies and process to manufacture it, plan and design the factory that will produce the product and manage the running and maintenance and continuous improvement of the manufacturing process. They may also be [...]
What is a CSV Specialist?
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. What is CSV? Computer Systems Validation (CSV) [...]
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. What is Calibration? Within a manufacturing environment, equipment is used [...]
What is a Production Supervisor?
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 [...]
What is Computer Systems Validation (CSV)?
Computer Systems Validation (CSV) is a process used to ensure (and document) that a computer-based systems will produce information or data in exactly way it was designed to do in an absolutely consistent and reliable manner. The process is used to replace paper with electronic data within highly regulated environments that directly impact [...]