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) is a process used to ensure (and document) that all computer-based systems will produce information or data that meet predefined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended.
The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. In these industries it’s crucial that any process within the manufacturing cycle reliably behaves in a consistent way.
Pharmaceutical manufacturing and medical device manufacturing industries are increasingly relying on computer systems to operate a range of manufacturing processes, so it’s more important than ever that these systems can be relied upon to follow a predetermined specification.
It is also a requirement of the industry’s compliance requirements, to ensure the safety of the final product.
What Does a CSV Specialist do?
The specific tasks may vary between roles, but example duties of a CSV specialist include:
- Writing, review and approval of validation SOPs and documentation
- Maintain accurate validation documentation
- Train other staff members on correct use of computerised systems in line with protocols and regulations
- Keep up to date with advances in the field and, in particular, the regulatory requirements
- Involvement in review and updating of validation documentation
- Review and analyse validation data – compiling reports when required
- Recommendation of process upgrades and improvements in efficiency
- Implementation of such improvements
- Involvement in both internal audits and external inspections as required
Becoming a CSV Specialist
Computer Systems Validation is a highly specialised field. Most candidates will be expected to have a BSc level education (usually technical or scientific) as well as specific training on CSV principles. Extensive work experience and specific CSV training may provide an alternative route to employment.
Some of the skills required to be an effective and successful CSV Specialist include:
- Organisational skills – must be able to use own initiative to organise workload, maintain current best practices and keep up-to-date with changes and modernisation within the field
- Communication skills – will be required to work alongside a multidisciplinary team to achieve effective validation. Good verbal communication skills are required but excellent written communication skills (particularly in technical writing) are essential
- Time Management Skills – often working on a project, must be able to prioritise tasks and maintain project timelines
- Analytical & Problem Solving Abilities – will be required to analyse requirements and processes before establishing an effective CSV protocol. When working in a pre-existing system, must be able to troubleshoot problems quickly and effectively
- Attention to detail – it is essential that implementation of validation protocols is carried out in a precise manner and that documentation reflects that. Must also be able to spot deviations from expected results quickly, taking corrective action as required
What is the Salary for a CSV Specialist?
For specific information on CSV specialist salaries, check out our Salaries Page.
Want to Know More About CSV Specialist Opportunities?
As manufacturing processes become increasingly automated, the need for CSV professionals is growing. This trend is only expected to continue.
There is also an acute shortage of trained CSV professionals in certain geographic areas, including Ireland. As a result, salaries for these roles are extremely attractive.
If you have the skills outlined above, as well as experience of pharmaceutical or medical device manufacturing, you might be closer than you think to being a great candidate for CSV roles within pharmaceutical companies.
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