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General Information

Company
Deloitte
Business Unit
Strategy, Risk & Transactions Advisory
Primary Location
Zaventem
Field of interest
Technology
Industry Focus
Industry Agnostic
Recruiter
Vandiest, Jasper - jvandiest@deloitte.com

Description of the position

Your journey with us

As a Computer System Validation (CSV) Engineer Consultant, you will support our clients in the Life Sciences & Health Care industry in ensuring their IT systems are compliant, robust and audit ready.

You will:

  • Plan and coordinate IT quality / computer system validation (CSV) projects and/or IT audits for GxP environments.
  • Advice on regulatory compliance, IT quality and CSV in support of business and IT stakeholders.
  • Define validation strategies and risk based approaches, aligned with regulations, standards and client processes.
  • Create and maintain validation deliverables, such as validation plans, risk assessments, user requirements, test protocols (IQ/OQ/PQ), traceability matrices and validation reports.
  • Plan and coordinate validation testing, working closely with business users and IT teams as independent quality advisor.
  • Perform system audits and gap assessments to verify compliance with good practices (e.g. GxP, data integrity) and regulatory requirements.
  • Support the design and implementation of Quality Management Systems (QMS), including processes, procedures and templates related to IT quality and CSV.

You’ll work in multidisciplinary teams and have the opportunity to contribute to both project based assignments and long term managed services engagements.

Let's talk about you

You are passionate about quality, regulatory compliance and technology, and you feel at home in a structured, regulated environment.

You have:
  • 2 to 6 years of experience in IT quality, computer system validation (CSV) and/or IT audit.
  • A good understanding of Quality Management Systems (QMS) and related processes.
  • Understanding of regulations and industry standards
  • Experience working in Life Sciences & Health Care (pharmaceutical, biotech, medical devices, hospitals, etc.).
  • Fluency in English. Dutch and/or French are a plus.
  • Strong organizational skills, with the ability to prioritize and coordinate multiple activities.
  • Diplomacy, creativity and a client and result oriented mindset, combined with excellent social and communication skills that allow you to build trust with both business and IT stakeholders.

If you recognize yourself in this description and you want to grow as a trusted advisor in CSV and IT quality, we’d love to meet you.

Our story
Our Risk, Regulatory & Forensic practice is a global leader in helping clients manage risk and uncertainty from the boardroom to the network. We provide a broad array of services that allow our clients around the world to better measure, manage and control risk to enhance the reliability of systems and processes throughout their organization.
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