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Becoming an Expert in CSV - Why and How?

Ben Pope our consultant managing the role
Posted by Ben Pope
Published on 15 August 2023

What is CSV?

The life science industry employs 248,000 people in 5,870 businesses, generating a turnover of £78.8b. Within this, industries such as pharmaceuticals, medical devices, and biotech rely on computer systems for research and development, clinical trials, manufacturing, and distribution.

Computer System Validation (CSV) is a process which ensures that the computer systems are developed, implemented, and maintained. In life science industries, this process acts as a critical component of ensuring the safety and efficacy of pharmaceuticals, medical devices, and biotech products. 

Increasing technologisation influences companies to remain vigilant in efforts to validate their computer systems and ensure they meet the requirements of predefined GxP (Good Practice) guidelines and pharmaceutical regulations. The process involves a set of activities, including planning, testing, documentation, and maintenance, which are performed throughout the lifecycle of a computer system.

Why Should You Become an Expert in CSV? 

Working as a CSV engineer is a niche career choice which requires a thorough understanding of regulation, validation processes, and quality assurance practices. Becoming trained in CSV, therefore, makes you a highly attractive candidate.

It can be incredibly rewarding as it involves ensuring that computer systems used in regulated industries are compliant, reliable, and secure. It’s a critical role in maintaining data integrity, regulatory compliance, and patient safety. Having CSV experience has also been found to increase your salary by 10-15%. Entry level CSV Engineers may earn between £30,000 to £40,000 annually. Annual salaries of CSV engineers with more experience, specialisation, or seniority can range from £50,000 to over £70,000.

Your Day Will Consist of: 

·         Compiling and reviewing validation data

·         Writing and reviewing validation documentation and protocols

·         Implementing process upgrades

·         Keeping on top of field advancements and updates to regulations

How to Become a CSV Expert

CSV is not just about coding and programming – you do not need to have a computer science background or even know how to program a PLC. CSV is about managing data accuracy, reliability and integrity so this background is not necessary.

Get Qualified

The minimum requirement for a CSV Engineer is to hold a bachelor’s degree in a science, engineering or technology focussed discipline. 

However, with it being a particularly specialised pathway, you may need to look into further specialist training or gain relevant experience with validation software within a related CQV role.

The qualification can be segmented into stages, such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

Build Your Skillset

Knowledge of cGMP and GxP: You must have a good grip on current Good Manufacturing Principles (cGMP) and a solid understanding of GxP computerised systems. These systems will encompass a variety of compliance and management software used to store data and keep the company in line with regulations.

Written communication skills: writing and reviewing reports, protocols and documents are a large part of the role. You must document your findings to succeed as a CSV engineer accurately.

Teamworking: you will likely work alongside a team of engineers within a wider CQV team, so you need to be able to work collaboratively. You will work with people across the manufacturing process and be able to discuss any defects found and plans to rectify them efficiently.

Detail-oriented: validation is an incredibly specific and detailed area of manufacturing. One small error could be catastrophic to the company, so you will need to be able to identify when something isn’t right and correct it quickly.

If you’re detail oriented, enjoy problem solving, and have an interest in technology and compliance, this role could be a good fit for you!

Get in Touch With Quanta

One last sure fire way to land your dream CSV job is to contact an expert Life Sciences recruitment agency like Quanta. 

We have worked in the Life Sciences recruitment space for over 20 years and are specialist Commissioning, Qualification and Validation (CQV) staffing suppliers. 

Check out our live life sciences job vacancies here or contact our team directly.