In the latest spotlight interview, we speak to Daniel Woods about his career path to becoming a Computer System Validation Lead working with highly technical pharmaceutical, biotechnology, and life science companies.
Daniel admits that back in his student days, he didn’t envisage a career in computer system validation (CSV) – in fact he hadn’t even heard of CSV. What he did enjoy, which is what ultimately set him on his path to a successful career with Scitech, is an interest in computer systems. “When I was at college I had dreams of becoming a music producer, which while it is obviously a vastly different career, also has a technical element. I have always had an interest in computer systems and that is what led me to where I am today.”
An unexpected career path
Daniel began working for a company specialising in small-scale, complex formulation sterile packing as a Machine Operator. “Originally, I intended this to just be a temporary summer job but an opportunity arose for an Operations Compliance role. Here, I took on computerised system projects, managing the implementation of these projects on site and also took on continuous improvement opportunities.”
Daniel went on to gain several years’ experience working within the pharmaceutical industry and building up contacts within the sector which led him to successfully secure a role within Scitech. Daniel said: “Many CSV engineers have a Computer Science or IT degree or a degree in Microbiology or Biotechnology. However, that isn’t the only route into a Computer System Validation role. On-the-job experience can also provide a gateway into roles such as this and experience is always going to be invaluable, particularly when the job – outside of the industry – is broadly unknown and when working in highly regulated sectors.”
The role of a CSV Engineer
Daniel explains that it is the role of Computer System Validation engineers to provide lifecycle support to the deployment and maintenance of all GxP computerised systems. “We are responsible for planning, writing, implementing and reviewing various life-cycle documents, including, but not limited to, validation plans, user requirement specifications, vendor design documents, code reviews, FAT/SAT protocols, qualification protocols, Data Integrity assessments, risk assessments, etc., to ensure the computer system(s) meet GxP regulatory requirements and function efficiently and effectively. This applies to new equipment or facilities and includes changes to existing processes, products, systems, and facilities. Essentially it is the responsibility of the CSV engineer to ensure that the GxP computerised systems are fit for purpose and operate as intended.”
Daniel has since gone on to achieve two internal promotions and is now a Computer System Validation Lead at Scitech. He now manages a team of Computer System Validation Engineers. “At Scitech we have a really positive culture that nurtures professional and career development. I have been able to draw on the experience of other senior team members, and there is always the opportunity to attend conferences and events to ensure that we are fully abreast of industry trends and regulatory updates. In turn, I make sure that I am equally as supportive to my team by running development sessions to further expand their knowledge and capabilities.”
The future of CSV: a rising demand
Daniel believes that the need for Computer System Validation Specialists is only going to grow in the future as equipment, systems and processes become increasingly reliant on computerised systems to drive them. Regulators also expect organisations to rely on computerised systems more to support their processes. This is further supported by the recent GAMP 5 Second Edition guidance which includes great initiatives like critical thinking and modern testing methods that’s really exciting to see and provides some great opportunities for organisations and CSV professionals alike. “The beauty of working in this role within a highly technical sector is that the different technology keeps you challenged-; which keeps it interesting. It’s also interesting seeing how different organisations have different yet similar challenges in the implementation of computerised systems. If you have an interest in computer systems then this would definitely make an interesting career choice.”
● Find out about the career opportunities at Scitech.