CSV Engineer

What does a CSV Engineer do?

As a CSV Engineer in pharma you plan, write, implement and review the computer systems validation (CSV) protocols in place. This highly specialist role within engineering ensures that all computer-based systems for GxP (good practice regulations and standards) are operating as intended and meet regulatory requirements. In such a highly regulated industry as pharma, you need to ensure that the required documentation to back this up and demonstrate compliance is correct and complete.

Take a look at the CSV Engineer vacancies to see which are the best fit for you!

What role and responsibilities can you expect as a CSV Engineer?

Your role and responsibilities as a CSV Engineer will vary according to the organization, but are likely to combine tasks such as proposing and implementing improvements with reviewing, maintaining and updating key documentation in accordance with current regulatory requirements.
In summary, these tasks may typically include the following:

• Documentation – writing, maintaining, reviewing and updating validation documentation, and approving validation SOPs;
• Reviewing validation data, compiling reports and contributing to internal audits and external inspections as they arise;
• Proposing and implementing process upgrades and efficiency improvements;
• Keeping on top of advances in the field and, in particular, updates to the regulatory requirements;
• Training staff on the computerized systems in line with the relevant protocols and regulations.

You like using your specialist skill set in a key role as Computer Systems Validation (CSV) Engineer? Browse our CSV Engineer vacancies

What education and skills do you need as a CSV Engineer?

To be a CSV Engineer, you need a mixture of a technical or scientific/engineering degree and either work experience or specialist training in CSV – and preferably both. It is an advantage to already have a sound knowledge of quality control in a pharma setting. As documentation is a key element, your written communication needs to be first class, but being well organised with the ability to work within a team and across disciplines is also important.
Required skills are likely to include:

• Technical ability such as a sound knowledge of quality principles (e.g. ISO 9001) and computer system development lifecycles;
• A keen attention to detail with natural curiosity and learning agility;
• Good communication skills across a wide range of departments within the organization and an ability to engage with stakeholders to achieve the business objective;
• A resilient, agile nature with excellent organizational ability to be able to priorities your workload to meet deadlines and deliver in a constantly changing environment.

What salary can you expect as a CSV Engineer?

Depending on the type and size of organization, your qualifications and experience and the role on offer, you can expect a salary of between €58.320,- and €77.800,- per annum in the Netherlands. With more experience, you could progress to CSV Lead, Automation Lead or IT Director roles.

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