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.
Computer system validation engineer
Who we are looking for
- You have a master’s degree in science or IT
- You have at least 1 year 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