CSV Specialists 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) and 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.
Note: Some Companies Might Call This Role: CSV Engineer
CSV Specialist Salaries & Job Growth
SALARY RANGE of US$45,000 – 85,000 based on US job data.
Also, please check out our salary guide for CSV Specialists and Automation Engineers local to you.
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
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
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.
One of the single biggest misconceptions of the CSV role is that you need to be able to code. This is usually not the case. However, we do some times see a requirement for the ability to code in some roles where the job description overlaps with automation engineering. And you do need a solid understanding of the computer process you will be validating.
Generally, CSV roles fall into two broad categories. It could be a stand-alone career. Some typical job titles we see advertised are:
- Computer System Validation Specialist
- Computer Systems Validation Engineer
- Senior Computer Systems Validation Engineer
- CSV Engineer
Or it could be an additional skill-set or job responsibility added to your current responsibilities.
The body of knowledge in CSV would not be broad or deep enough to constitute a stand-alone undergraduate degree. The techniques used are usually added onto a lab/science or engineering qualification or learned on the job. We have studied numerous job advertisements for CSV roles and the particular undergraduate degree requirements loosely fall into these brackets but please note, there are a lot of exceptions.
For those people who will be validating
- Laboratory Information Management System (LIMS)
- Laboratory Instrument Systems (LIS)
- Clinical Trial Monitoring Systems
- Chromatography Data System (CDS)
The job descriptions tend to look for those with a laboratory/science chemistry background.
For those people who will be validating:
- PLC for Controlled Packaging Equipment
- Supervisory Control and Data Acquisition (SCADA)
- Distributed Control System (DCS)
- Manufacturing Execution System (MES)
- Enterprise Resource Planning (ERP) Systems
- Batch Record System
- Building Management Systems (BMS)
- OSI PI Systems
The job descriptions may look for those with an automation, instrumentation or calibration, computer science, computer engineering, computer information systems background.
But as we said before, there are a lot of exceptions.
Computer System Validation Course
Go rapidly from total beginner to an advanced level CSV expert.
Check out our 10 week Computer System Validation course
This program will teach you how to apply CSV to your projects immediately and turn your work experience into an Advanced Certification.
- Anyone with an understanding of GMP rules and regulations
- Validation Engineer or Specialist
- Senior Validation Manager
- Automation Engineer
- Control/Instrumentation Engineer
- Process Engineer or Project Engineer
- Quality Assurance or Quality Control Specialist
- Maintenance Engineer or Technician
…who want: to get their GAMP®5 and 21 CFR Part 11 projects under control!
Duration: 10 weeks
Delivery: Completely Online
Awarding body: GetReskilled
Computer Systems Validation Course
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
For more help with your resume, check out these templates and this list of 30 tips to improve your resume.
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 and the UK.
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