About this role
Why This Job is for You At Knightec, we understand that validation is more than just documentation. It's about collectively reaching common goals - delivering a secure product and improving users' quality of life. 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 like to document. You will become part of our Validation Management competence area 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 MedTech Compliance initiative where professional development and collaboration are the focus.
Within our Compliance & Management business area, we support an effective 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 varying roles supporting our customers where your expertise will be most effective. 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 deployment, providing opportunities to influence results and outcomes.
Qualifications We are seeking someone who is quality-conscious and enjoys learning and sharing knowledge with others. You have a technical interest and are attentive. Beyond your personal characteristics, we want you to have:
• Quality-oriented approach and a desire to develop yourself and your colleagues
• Engineering degree in biotechnology, medical technology, chemical engineering, computer technology, or similar
• Independently driven validation work within Life Science and responsible for DQ/IQ/OQ/PQ phases
• Experience with requirement and deviation management
• Good knowledge of GxP regulations, especially GAMP5, 21 CFR part 11, and Eudralex Annex 11
• Strong communication skills 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 incredible 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 help shape the future through meaningful projects at the absolute technological forefront. Here, you will not only develop and grow but also become part of something larger.
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 at Ångbåtsbron 1, Malmö, or our office in Helsingborg, Stortorget 11. Business travel to our customers may occur. Start date is as soon as possible or by agreement.
Submit your application as soon as possible, but no later than 2025-12-07. If you have any questions about the position, please contact Lina Orfanidou, Talent Acquisition Specialist. Please note that, due to GDPR, we only accept applications through our career page.
We look forward to hearing from you!