Vacant job

Why this job is for you

At Knightec Group, we understand that validation is more than just documentation. It is about achieving common goals together – delivering a safe product and improving the quality of life for users. You enjoy seeing the big picture, from initial requirements to the end result of a fully validated process, equipment, or system. You are meticulous and enjoy documenting your work.

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

Within our business area Compliance & Management, we support an efficient transition to digital, sustainable, and secure solutions through expert knowledge in areas such as quality, safety, sustainability, and project management.

Responsibilities

You will take on varied roles where you support our customers 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.
• Participation in requirements definition, design, procurement, and commissioning, giving you the opportunity to influence results and outcomes.

Qualifications

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

• A quality-oriented approach and a desire to develop yourself and your colleagues.
• An engineering degree in biotechnology, medical technology, chemical engineering, computer engineering, or similar.
• At least three years of experience independently driving process validation work within Life Science, with responsibility for the DQ/IQ/OQ/PQ phases, focusing on CSV equipment, packaging, and cleanroom environments.
• Experience with requirement and deviation management.
• Good knowledge of GxP regulations, especially GAMP5, 21 CFR Part 11, and Eudralex Annex 11 and/or ISO 13485.
• Fluency in both Swedish and English.

An exciting journey with Knightec Group

Semcon and Knightec have joined forces 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 customers realize their strategies – from idea to finished solution. At Knightec Group, we have the competence, attitude, and drive required to take on the most challenging and innovative projects.

For our employees, this means fantastic opportunities to shape the future through meaningful projects at the absolute 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 probation period, located at our office in Malmö (Ångbåtsbron 1) or Helsingborg (Stortorget 11). Travel to our customers may occur as part of the role. Start date is by agreement.

Please submit your application as soon as possible, but no later than 2026-06-21. If you have any questions about the position, you are welcome 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!