What is a CSV Engineer?

CSV Engineers plan, write, implement and review the Computer Systems Validation protocols in place within highly regulated industries. Their work is essential to make sure that all GxP computer-based systems are operating as intended (with documents to prove it) and meet regulatory requirements.

Note: Companies also might call this role:

• CSV Specialist
• CSV Support Analyst
• CSV Subject Matter Expert
• CSV Lead

And if you need to learn CSV, check out our Computer System Validation Training Course.

Computer Systems Validation (CSV) is a process used to ensure (and document) that all computer-based systems does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.

The process is used to replace paper and/or handwritten signatures with electronic data in highly regulated environments that impact public health and safety such as the pharmaceutical and medical device industries. These sectors use computer systems to operate and record a range of processes and activities from manufacturing, product testing, distribution, storage, logistics, etc so it’s critical that these systems can be relied upon to:

• produce data accurately and consistently.
• create an indelible electronic data trail that is transparent, traceable and tamper-proof.
• store those electronic data records in a way that is safe, secure and can stand the test of time.

It is also a requirement of the industry’s compliance requirements, to ensure the safety of the final product.

The pharmaceutical and medical device industries are regulated, meaning that what goes on inside the factory walls are subject to the law of the land. In the 90s, the regulatory authorities for these industries took the decision to replace paper records and handwritten signatures with electronic records.

And CSV is a process that creates an indelible electronic data trail that allows us to treat regulated data and electronic signatures captured in drug discovery, drug trials, manufacturing, distribution and storage as the legal equivalent of paper records and handwritten signatures and have the equivalent level of confidence in their accuracy, reliability and data integrity.

SALARY RANGE of US$78,000 – 109,000 based on US job data.

Also, please check out our salary guide for CSV Engineers local to you.

Typically a CSV engineer will have to manage electronic data in a regulated manufacturing/laboratory/clinical environment in compliance with FDA 21 CFR 11 or other regulatory guidelines using the GAMP lifecycle framework. Think of the controls outlined in the FDA’s 21 CFR 11 as what the regulators want to see the computer system be able to do. Think of GAMP as the approach or framework you take to achieve those controls.

The specific tasks may vary between roles, but example duties of a CSV Engineer include:

• Write, 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

The ideal skill set for someone moving into CSV includes:

• Excellent stakeholder management skills – this role requires working with people from across the product lifecycle from, research, clinical trials manufacturing, quality assurance,  quality control, distribution, project managers, and others to discuss adherence to protocols and implementation of new SOPs. You need excellent people management and negotiation skills!
• Teamworking – CSV engineers and specialists often work in project teams and across departments
• GMP rules and regulations – solid understanding of Good Manufacturing Practice (GMP) rules and regulations
• GxP computerized system applications – solid understanding of the variety of these types of computerized systems
• 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
• Excellent written communication – a bias for 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

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 sometimes 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:

• CSV Engineer
• Computer System Validation Specialist
• Computer Systems Validation Engineer
• Senior Computer Systems Validation 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.

And so it could be argued that a CSV Engineer is not really a standalone engineering profession in and of itself but a job title given to those who already have a relevant engineering or lab science qualification and do this type of work. But whatever your opinion on the matter, the job title “CSV Engineer” is by far the most commonly used for this type of work.

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 as you would be more likely to have deep experience using these kinds of systems and would understand the functional layout.

For those people who will be validating:

• PLCs 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 automation, instrumentation or calibration, computer science, computer engineering, or a computer information systems background.

But as we said before, there are a lot of exceptions.

Go from beginner to a CSV expert.

Check out our 10-week Computer System Validation CSV Training course

This program will teach you to manage electronic data in a regulated manufacturing/laboratory/clinical environment in compliance with FDA’s 21 CFR Part 11 or other regulatory guidelines using the GAMP framework

Computer Systems Validation Training Course

As with all resumes, it’s extremely important that you tailor your CSV Engineer’s 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.

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 Engineer roles, head to our jobs boards and select Validation in the “Jobs by Category” menu. We currently have job boards for Ireland and the UK.

Validation

• Validation Engineer
• CQV Engineer
• Validation Technician