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.
Some Companies Might Call This Role…
- CSV Engineer
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 the correct use of computerized 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 analyze 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 specialized 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.
If you want to know more about making a mid-career change into this area, the first step is our 30-week conversion certificate course eBioPharmaChem.
What Skills Do I Need?
The ideal skill set for someone moving into CSV includes:
- Team working – Quality Control Associates often work in teams to gather and analyse data
- Keen attention to detail – must be able to quickly spot when something isn’t correct and take effective action, catching a problem early can reduce wasted time and product
- Good communication skills – this role requires working with people from across the manufacturing process and often working with production staff to discuss defects, adherence to protocols and implementing new quality SOPs.
- Excellent written communication – documentation is a key feature of these roles and an essential requirement of industry compliance
- Prioritisation skills – often working to deadlines and ensuring the manufacturing process is working efficiently at every stage, must be able to prioritise workload
CSV Specialist Salaries & Job Growth
Check out our salary guide for Quality Control Associate salary information local to you.
CSV Specialist Resume Tips
As with all resumes, it’s extremely important that you tailor your CSV Specialist resume to reflect the language used within the job advert. Where you have relevant experience or skills, use the words and phrases that the employer has used to describe them. Do not assume that someone will read similar wording and know what you mean.
CSV Specialist roles will typically be looking for the skills previously outlined:
- Organisational skills
- Communication skills
- Time Management Skills
- Analytical & Problem Solving Abilities
- Attention to detail
CSV Specialist Job Vacancies
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 the 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.
For more information on currently available CSV Specialist roles, head to our jobs boards and select Validation in the “Jobs by Category” menu. We currently have jobs boards for Ireland, the UK, and Philadelphia, USA.
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