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Job Advertisement: Validation Specialist at Knightec Group

Knightec Group AB

Skåne län, Malmö

Previous experience is desired

24 days left
to apply for the job

Why this job is for you At Knightec Group, we understand that validation is more than just documentation. It’s about achieving common goals together - delivering a safe product and improving the quality of life for users. You enjoy seeing the big picture from the beginning with requirements to the end with a fully validated process, equipment, or system. You are meticulous and enjoy documenting.

You will be part of our area of expertise in Validation Management where you will participate in workshops, mentorship programs, and discussion forums that promote knowledge sharing and collaboration. You will also be part of our national initiative in Medtech Compliance where professional development and collaboration are in focus.

Within our business area Compliance & Management, we support an effective transition to digital, sustainable, and safe solutions through expert knowledge in areas such as quality, safety, sustainability, and project management. Responsibilities You will take on varying roles where you support our clients and where your expertise comes into play. You will work with:

  • Validation and qualification of processes, equipment, and computerized systems within the Life Science industry.

  • Participating in requirements setting, design, procurement, and commissioning, giving you the opportunity to influence results and outcomes.

Qualifications We are looking for someone who is quality-conscious and enjoys learning new things and sharing knowledge with others. You have a technical interest and are attentive. In addition to your personal qualities, we want you to have:

  • A quality-oriented approach and a desire to develop yourself and your colleagues

  • A degree in biotechnology, medical engineering, chemical engineering, computer engineering, or similar.

  • At least three years of experience independently driving work with process validation within Life Science and being responsible for DQ/IQ/OQ/PQ phases, with a focus on CSV equipment, packaging, and cleanrooms.

  • Experience in requirements and deviation management.

  • Good knowledge of GxP regulations, especially GAMP5, 21 CFR part 11, and Eudralex Annex 11 and/or ISO13485.

  • Fluency in both Swedish and English

An exciting journey with Knightec Group Semcon and Knightec have merged as Knightec Group. Together we form Northern Europe's leading strategic partner in product and digital service development – how cool is that?

With a unique combination of cross-functional expertise and a holistic understanding of business, we help our clients realize their strategies – from idea to finished solution. At Knightec Group, we have the competence, attitude, and drive needed to take on the most challenging and innovative projects.

For our employees, this means fantastic opportunities to help shape the future through meaningful projects at the forefront of technology. Here, you will not only develop and grow but also become part of something bigger.

Does this sound like the place for you? Join us on an exciting journey!

Practical information This is a permanent position with a six-month probationary period, located at our office in Malmö, Ångbåtsbron 1 or at our office in Helsingborg, Stortorget 11. Travel may occur to our clients. Start date is according to agreement.

Please submit your application as soon as possible, but no later than 2026-04-19. If you have any questions about the position, feel free to contact Oliver Rydberg, Talent Acquisition Specialist. Please note that, due to GDPR, we only accept applications via our career page.

We look forward to hearing from you!

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