Category: Careers

Spotlight on Daniel Woods, Computer System Validation Lead

Posted on by Simon

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.

Exploring the opportunities that process and chemical engineering can provide for humanity: My week at Scitech

Posted on by Simon

Godalming College student, Jake, blogs about his week of work experience at Scitech.

From a very young age I have always been interested in how humans have helped people with medical illnesses or conditions to improve or extend their lives. In particular I am fascinated by how a seemingly small or insignificant thing such as capsule or tablet can help people live healthier and happier daily lives around the world. To me it encapsulates how human intelligence and endeavour has overcome challenges to make the world a better place. The science behind what happens in medicine is truly amazing! I am keen to study biomedical sciences at university and was extremely fortunate that Scitech agreed to offer
me one week’s work experience in July 2023.

Introduction to Scitech – a leading consultancy, engineering and construction company

I started my week with an office orientation and introduction to Scitech from my mentor Hazel. I was impressed to hear about the broad range of services and expertise Scitech offer to their customers ranging from mechanical engineering, architecture, process engineering to computer aided design and project management. In particular, I found the overview on building services very interesting because I had not considered how intrinsic planning makes sure the building is safe for use and also is needed before the project can even start. I was shown how the pressure gradients were controlled to ensure safety which I found interesting as I had learnt about pressure gradients in biology this year.

The monoclonal antibody manufacturing process

Hazel then introduced a research project they requested I work on during my week, for me to present back to a small group on Friday. It was exciting as not only was I being given a view of the type of work Scitech carry out, I was also being challenged to create something to deliver as though I was an employee of the company! I really appreciated being given this challenge so I could do my own research and think around a topic and be able to contribute back with some of my thoughts and ideas at the end of the week, rather than receiving information and trying to memorise them back as though I was at college. This is what I will need to do in a work environment so I thought it was a great idea and would help me to feel engaged and part of their team. In my case, I was asked to research on the monoclonal antibody (mAb) manufacturing process, which in a nutshell is an approach for creating a type of protein in a lab which can attach to cancer cells to diagnose and treat different cancers and other diseases.

Health and safety is everyone’s responsibility

On Tuesday I was given an overview of architecture from Matt, and health and safety from Brian, which was interesting as I learned that health and safety is essentially everyone’s responsibility in the office and we looked at some fascinating real life examples. I was also really impressed by the range of buildings implemented by Scitech.

Wednesday was when Nadira gave me an overview of building services where she explained how factors such as radioactivity and air circulation had to be considered. During most of the afternoon I carried on my research project and started to formulate my presentation structure as well as speaking to Ali about his take on the expanding world of biology.

On Thursday and Friday I worked fully on my project on my computer at my desk, making me feel as though I was an employee in an office conversing with colleagues. I spent the time creating a PowerPoint slide deck to deliver on Friday, and I tried to make sure I could create visually appealing slides with good content for the team to digest. In addition to this, Hazel gave an overview of many different types of laboratory equipment Scitech use, and then asked me to fill in the specifications of the equipment which was insightful.

On Friday, finally it was time to deliver my presentation to the group. I must say I was quite nervous, but I was able to get the main points across and answer the questions which were asked. I believe I was able to answer everything. When I told my parents about this they were amazed that in 1 week I was able to learn about Scitech and the pharmaceutical engineering industry, gain office experience and deliver a presentation in such a short time!

Highlights of the week

My three key highlights of the week were:

  • The research I did for the manufacture of monoclonal antibodies
  • Learning about process engineering
  • The overview sessions of architecture and building services

I would like to thank Scitech for giving me such a fascinating insight into their operations and culture. In particular Emma Dawas, Joanna Finch, Hazel Hatley and all members of staff who were extremely helpful and friendly, making the week such an unforgettable and incredible experience.

  • Read Adam’s work experience blog about how he gained an understanding of engineering and commercial management as he contemplates what career path to take.