What is a CSV Engineer and how do you become one?
Digitisation is transforming all corners of the pharmaceutical industry, particularly in areas that experience vast amounts of data handling. From drug discovery all the way through to drug manufacture, processes are becoming increasingly digitised, and with it comes a growing demand for qualified, tech-focussed talent. One particular role we are seeing a great need for in the current market is that of a CSV engineer.
What is CSV?
CSV, or Computer Systems Validation, is a niche specialism that exists within the validation stage of pharmaceutical manufacturing. Validation is vital for the safe and efficient production of medical products; it is when data from testing is gathered to show that the manufacturing processes are following regulation and consistently producing reliable results.
What does a CSV engineer do?
Responsible for planning, writing and reviewing computer protocols, CSV engineers make sure that all GxP computer-based systems are operating correctly. This includes providing documentation to show that the computerised systems and validation software are reaching current regulatory requirements.
Day to day, they will:
· Compile and review validation data
· Write and review validation documentation and protocols
· Implement process upgrades
· Keep on top of field advancements and updates to regulations
How do I become a CSV engineer?
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.
Build your skillset
- Knowledge of cGMP and GxP: You will need to have a good grip on current Good Manufacturing Principles (cGMP) as well as have 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 will need the ability to accurately document your findings to succeed as a CSV engineer.
- Team working: it is likely you will 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 efficiently discuss any defects found and plans to rectify.
- 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 quickly identify when something isn’t right and correct it.
Build your CV
As with all CVs, it is a good idea to tailor your CV to the specific role that you are applying for. Hiring managers and recruiters take an average of 6-7 seconds to assess a CVs suitability for the role. Ensure that you are matching your skillset to the job you are applying for, leading with your education, additional training and relevant experience. Don’t forget to make mention of the soft skills you also have that make you an excellent fit for the CSV Engineer job being advertised.
Get in touch with Quanta
One last sure-fire way to land your dream CSV job is to get in touch with an expert Life Sciences recruitment agency, like Quanta. We have been working in the Life Sciences recruitment space for over 20 years and are specialist Commissioning, Qualification and Validation staffing suppliers. Check out our live life sciences job vacancies here or get in touch directly with our team.