Why Choose a Career in Computer System Validation CSV?

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We get lots of enquiries about our Computer System Validation course from people who just aren’t quite sure if they’d be a good fit for it as a career.

So we thought we’d write a post that really breaks down CSV and who’d be a good match for it. Of course, we’re always here to answer your specific questions so if you’re still unsure by the end of this, you can chat with us by clicking on the blue chat bubble in the bottom right corner of the page. We’re always happy to help!

The simplest explanation is that Computer System Validation checks and (equally importantly) formally documents that any GxP computer system involved in the pharmaceutical or medical device industry does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.

The CSV 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 a permanent and unchangeable 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

For a much more detailed full rundown of what CSV is, check out the previous blog post “What is Computer Systems Validation in the Pharmaceutical Industry?”

And btw, if you need to validate these types of GxP software systems to meet regulatory requirements, or if you want to extend your or your team’s role into computer systems validation projects or charge higher hourly rates, check out our 10-week online Computer System Validation Training Course.

Far too many people assume that CSV is all about coding or programming, that you need to have a computer science background or that you need to be able to program a PLC.

We find lots of perfectly suitable candidates ruling themselves out because of these false assumptions.

CSV is about managing data accuracy, reliability and integrity – NOT programming*.
What you DO need is solid experience using the GxP computer process you are going to be validating and an understanding of its functional layout.
(* We very occasionally see a requirement for the ability to code where a specific job description overlaps with automation engineering.)

Computer System Validation (CSV) is applied to GxP computerised system applications.

GxPs is an umbrella term for several “Good Practice” regulatory frameworks.

Examples of the different frameworks include:

• Good Laboratory Practice (GLP) – used within drug discovery
• Good Clinical Practice (GCP) – used within drug trials
• Good Manufacturing Practice (GMP) – used within manufacturing
• Good Distribution Practice (GDP) – used within product distribution
• Good Storage Practice (GSP) – used within product storage

Examples of computerised system applications from across these GxP frameworks include:

• Laboratory Information Management System (LIMS)
• Laboratory Instrument Systems (LIS)
• Clinical Trial Monitoring Systems
• PLC for Controlled Packaging Equipment
• Supervisory Control and Data Acquisition (SCADA)
• Distributed Control System (DCS)
• Chromatography Data System (CDS)
• Enterprise Resource Planning (ERP) Systems
• Manufacturing Execution System (MES)
• Batch Record System
• Building Management Systems (BMS)
• Spreadsheets

There are basically two main reasons, and neither is very complicated…

Firstly, it pays well. The Pharma industry pays more than other industries for equivalent jobs across the board, but CSV professionals command particularly high salaries. We have been told by validation professionals working for engineering contractors that just having solid CSV experience under their belt can allow them to add anywhere from 10% to 15% to their hourly rates.

Secondly, there is an ongoing shortage of trained people. These roles can’t just be “learned on the job”, people wanting to work in them need specific training.

These reasons combined mean that anyone equipping themself with CSV skills is highly desirable in the job market and should be able to negotiate an extremely attractive package.

We want to be totally upfront – CSV is not for everybody.

CSV professionals deal with regulatory compliance and therefore need to be ultra meticulous and have a love of fine details and minutiae.

Rather than us trying to summarize the role for you, we thought we’d bring you the information directly from the industry. So here are quotes about the roles and responsibilities of a CSV professional taken from Pharma and Medical Device company job adverts in 2022.

• Implement and oversee the validation of GxP computerized systems to ensure compliance with applicable Good Manufacturing Practice (GMP) regulations, 21 CFR Part 11, EU Annex 11, corporate policies, and site Standard Operating Procedures (SOP’s).
• Prepare validation deliverables for computerized systems including:
  • Validation Plans
  • Requirements Specification
  • Configuration Specifications
  • Risk Assessments
  • Test Scripts
  • Traceability Matrices, and
  • Validation Summary Reports
• Schedule and manage vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols
• Ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements.
• Assist subject matter experts (SMEs) in the preparation of test scripts comprising formal testing of functional, system and regulatory requirements in conjunction with computerized system validation. Oversee test script execution.
• Work with Operations and Quality to assess risk and impact on any proposed changes within the facilities and validated processes. Participate in meetings associated with the scheduling of these activities to ensure minimal impact to existing operations.
• Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations.
• Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely manner.
• Participate in the development of corrective actions as needed for deficiencies that may be uncovered/observed during validation efforts in regards to equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues in order to assure compliance with applicable regulatory requirements/guidelines, procedures and policies.
• Participate in the development of CAPAs (corrective action, preventative action) and assess the effectiveness of the corrective action.
• Schedule validation project team meetings to assure project milestone schedules are maintained and deliverables satisfy requirements.
• Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI’s maintained.

Generally speaking, anybody who has significant experience using at least one GxP computer process (in clinical trials, manufacturing, product testing, distribution, storage, or logistics) and understands its functional layout is a suitable candidate for CSV.

Some typical examples include:

• Validation Engineer, Specialist or Managers
• Quality Assurance or Quality Control Technician or Specialist
• Biochemists, Microbiologist, Molecular Biologists, Laboratory /Scientists, etc
• Automation, Control/Instrumentation Engineers or Technicians
• Process, Chemical or Manufacturing Engineer or Technicians
• Metrology, Maintenance Engineer, Technician or Specialist
• Front/Backend Developer

And it’s worth noting that, generally, CSV job roles generally fall into two categories.

1) Stand-Alone Job Role

Firstly, they can be a stand-alone job role. Some typical job titles we see advertised are:

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

2) Additional Skill-Set

Secondly, they can be an additional skill set or job responsibility added to your current job role.

For example, people already working within the Validation and Quality departments of Pharma or Med Device companies can often find themselves suddenly tasked with CSV responsibilities. The familiarity these professionals have with the regulatory requirements of the industry and their awareness of the company’s Quality processes make them ideally suited to do this (often as an extension to their current work, and not necessarily as a new standalone position).

We have studied numerous job advertisements for CSV roles and the particular desirable backgrounds loosely fall into the following brackets (but please note, there are a lot of exceptions).

For people validating the following GxP computerized systems:

• Laboratory Information Management System (LIMS)
• Laboratory Instrument Systems (LIS)
• Clinical Trial Monitoring Systems
• Chromatography Data System (CDS)

The job descriptions tend to look for candidates with a laboratory/science chemistry background. This makes sense as you would be more likely to have deep experience using these kinds of systems and would understand their functional layout.

For people who will be validating the following systems:

• PLCs for Controlled Packaging Equipment
• Supervisory Control and Data Acquisition (SCADA)
• Distributed Control System (DCS)
• Manufacturing Execution System (MES)

The job descriptions may look for candidates with automation engineering, process engineering, chemical engineering, instrumentation or calibration engineering experience. In some cases, you may need to be able to program a PLC.

For people who will be validating:

• Enterprise Resource Planning (ERP) Systems
• Batch Record System
• Building Management Systems (BMS)
• OSI PI Systems

The job descriptions often look to candidates with validation, production management, inventory control, computer engineering, computer information systems, logistics or maintenance engineering experience.

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

If you need to validate these types of GxP software systems to meet regulatory requirements, or if you want to extend your or your team’s role into computer systems validation projects or charge higher hourly rates, check out our 10-week online Computer System Validation Training Course.