Computer System Validation Engineer

About Synthon

Synthon Biopharmaceuticals focuses on development of innovative medicines, including antibody-drug conjugates, in two key therapeutic areas: oncology and autoimmune diseases. In the
coming years, we aim to deliver on our promise to introduce new medicines for diseases with high unmet medical need.

We are inquisitive, entrepreneurial and independent. We make creative choices, and are building a promising portfolio of next-generation medicines.

Synthon Biopharmaceuticals is based in Nijmegen, the Netherlands, where close to 350 staff work at our state-of-the art biotech campus.

We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to our ambition to provide solutions to the healthcare challenges of today and tomorrow.

Job profile

We are looking for a Computer System Validation Engineer to join the Synthon Biopharmaceuticals IT team. In this position, you will be responsible for safeguarding all validation activities related to computer system implementation, lifecycle renewal and upgrade projects. The qualified candidate will have strong experience in supporting computer system validation efforts for applications used in GMP (GxP) processes, ensuring adherence to internal procedures and applicable regulations such as 21 CFR Part 11, Annex 11 and cGMP. You will also monitor and participate in IT related change control and deviation processes.

To make this happen, teamwork is essential. In your role as Computer System Validation Engineer you will collaborate across functions within the Information Technology department, with various departments within Synthon Biopharmaceuticals, including Quality Assurance, and with external vendors and consultants, to plan, coordinate, improve and execute computer system validation activities. You will report to the head Information Technology.

Your responsibilities include:

  • Safeguarding validation activities related to computer system implementation, renewal and upgrade projects (ERP, QMS, EDMS, LIMS, ELN and others), analyze and summarize qualification and validation results.
  • Performing, assisting and advising in risk assessment exercises in support of computer system validation.
  • Coordination of the creation, update and review of validation deliverables such as user requirements, functional specifications, validation plans, protocols, test scripts, traceability matrices, summary reports, procedures and work instructions.
  • Assisting in training with regard to computer system validation, quality practices and/or applicable regulations as needed.
  • Performing internal evaluations to verify compliance with procedures.
  • Initiate, contribute and write procedures and work instructions related to computer system validation and computer system management.

Your profile

  • A Bachelor’s degree or equivalent in computer science, engineering or related field.
  • Minimum 5 years experience in computer systems validation in a regulated industry (e.g. pharmaceutical, food).
  • Experience in supporting computer system validation efforts including the creation, update and review of computer system validation deliverables.
  • Proven knowledge of 21CFR11, Annex 11, ITIL, GAMP5, GxP or comparable regulations and guidelines (ISO27001 or Sox).
  • Outstanding command of the Dutch and English language.

In interviews you will be able to demonstrate that you have experience with electronic document and quality management systems, project management, change management, deviation management, risk assessments regarding computerized systems and the qualification of infrastructure components and virtual systems. You have an open mind, embracing creative, innovative, flexible and practical approaches to improve practices and solve problems. In addition, you are able to quickly build and maintain relationships with your colleagues and your internal customers.

What Synthon offers you

  • A position in which you play an essential role in correctly building the new IT environment of Synthon Biopharmaceuticals.
  • Salary of 44-66K per year (+ variable salary), depending on experience.
  • 30 vacation days.
  • Flexible start times (07.00h – 09.00h).
  • Working with enthusiastic colleagues in an advanced R&D environment.
  • A pleasant workplace at our easily accessible office in Nijmegen.


For further information, you can contact Bram de Kruijff, Site director at tel. +31 (0)24 - 372 77 00. If you are interested in this challenging position, we look forward to your application. Please send your application via the apply button / link. 

Recruitment by commercial agencies in relation to this or other vacancies is not appreciated.

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