Computer System Validation Engineer to Malmö

Why should you want this job?
Because you know that validation is much more than documentation. You know that it's about being the glue in getting everyone to work towards a common goal - a safe product and improved life quality for the user.

You'll get to work with people really skilled in the area of validation and qualification. The environment is built on collaboration, making it possible for you to take on projects outside your skillset since you will be equipped not only with your competence but the combined expertise of Knightec.

The core is validation and qualification of computerized systems, processes, and equipment within the Life Science industry. But that's not all. You will be able to take on a lot of responsibility in your projects, including being involved in the design, purchasing, and commissioning, allowing you to have a real impact on the result.

The common ground is teamwork, quality, and knowledge-sharing. The way forward is in your hands. You are the one with the skills and know-how, and we want you to tell us how to use it, not the other way around.

Build a career that you can be proud of
Wherever you see yourself in the future, we are here to support you. No matter if you would like to take on a new role, become a specialist within a specific area, or develop your managerial skills - we will help you find the way forward. Your will and ambition will lead the way; we provide the training arena needed to reach your goals.

To stimulate your development, you'll be part of our initiative Validation Management; a competence-group started to enhance knowledge-sharing and collaboration. Through activities such as workshops, mentorship-programs, and discussion forums, you'll be able to accelerate your learning curve, preparing you to take on the next challenge. And when you do, you always have your colleagues behind ready to support. Because everything we do, we do together.

These are the skills you need to bring
You bring a quality-oriented mindset but, most importantly, a will to develop yourself, learn new things, and share your knowledge.

You also have:

- Engineering degree in the field of biotechnology, medical engineering, chemical engineering, or similar
- Experience from working with validation of computerized systems in the Life Science Industry where you have been part of the IQ/OQ/PQ-phases
- Good knowledge of the GxP-regulation. Positive with knowledge of GAMP5, 21 CFR part 11, and Eudralex Annex 11.
- Fluent in Swedish and English


One Knightec
Knightec is a new breed in the art of engineering with over 750 colleagues in ten locations around Sweden. We are consultants with our soul in digitalization who strive forward together.