As a computer system validation engineer, you offer support in the implementation of software systems used in the lab and production environment within the pharmacy: mobile apps, medical devices, websites, HPLC software, etc. You are responsible for setting up and implementing a risk-based validation strategy, taking into account internal procedures and regulations: Cfr21 Part 11 / Annex 11. You are in contact with quality assurance, IT and business to identify the system requirements and link needed actions to them.
Medior/senior computer system validation engineer
Who we are looking for
- You have a master’s degree in science or IT
- You have at least 3 (medior) or 7 (senior) years of experience in the validation of computer systems
- You are familiar with GAMP5, Part 11, Annex 11, GMP, etc.
- Knowledge of agile development methods is a plus
- You can document in a professional way
- You are good at analytic thinking, prioritising and planning
- You communicate fluent and clearl in English, Dutch is a plus
- You have a strong sense of responsibility and an eye for quality
- You are eager to learn and evolve
What we offer
- You contribute to projects for top companies, both national and international
- You work in a hightech environment with a focus on knowledge and innovation
- Your colleagues are down to earth and open to new ideas and initiatives
- Your knowledge is kept up to date by participating in workshops, training sessions and conferences
- You can give direction to your career
- You benefit from advantages such as a company car, laptop, telephone benefit, insurance, etc.
- You can optimize your net salary thanks to our IP-reward