Computer system validation engineer

As an experienced computer system validation engineer, you will support the implementation of software systems that are used in laboratory and production environments within the pharma industry. It will be your mission to guarantee the quality of these software systems. Within software validation there is a very wide range of possibilities. CSV projects can range from simple Excel sheets, medical devices, websites and HPLC software to complex systems that are used across multiple departments, throughout the site or even internationally: MES, LIMS, SAP, etc.

  • You will be responsible for independently setting up and documenting a risk-based validation strategy
  • Together with the business units concerned, you will draw up requirements and test protocols
  • You will report results according to internal procedures and predefined templates
  • You will assist the customer with regard to compliance with regulations such as Cfr21 Part 11/Annex 11
  • You will be in close contact with different stakeholders and understand the interests of Quality Assurance, IT and the business
  • You will be jointly responsible for determining the impact of changes and drawing up deviations
  • You will help draw up and adapt work instructions and SOPs

Who we are looking for

  • Graduated with a Master’s degree in a scientific discipline (Industrial Engineering, Bio-Engineering, Chemistry, Biotechnology, Pharmacy, etc.) or equivalent through experience
  • Knowledge of Validation within a GMP environment
  • Familiar with the standards and guidelines (GAMP5, GMP, 21CFR Part 11, ISO, etc.) and concepts such as QMS, Data Integrity, CAPAs, GDP, etc.
  • Affinity for IT and knowledge (at least in general terms) regarding the set-up of IT infrastructure
  • Knowledge of Agile development methods is a plus
  • Ability to think analytically and pragmatically, prioritise and plan
  • Strong sense of responsibility and punctual
  • Can communicate fluently and clearly in Dutch and English

What we offer

  • You will contribute to projects for top companies, both nationally and internationally
  • You will work in a high-tech environment with a focus on knowledge and innovation
  • Your colleagues are down-to-earth and open to new ideas and initiatives
  • Your knowledge will be kept up to date by participating in workshops, training courses and conferences
  • You will help direct your career and have the chance to grow
  • You will enjoy benefits such as a company car, laptop, phone allowance, insurance, etc.
  • You can optimise your net salary thanks to our IP reward

Apply now

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  • Accepted file types: pdf, docx.
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