Vacant job

Why this job is for you You want to make a real difference as a consultant within Life Science. Together with our customers, we contribute to improving people's lives and quality of life by developing production, quality, and project operations. You will become part of a team of experts in validation, helping our customers achieve safe products and make a difference for the end user.

Here, you and your development are in focus. You will have a continuous dialogue with your manager regarding future development opportunities to shape a plan that suits you and your ambitions – all to ensure you develop and work in assignments and roles where you thrive and your expertise is utilized. You will be part of our validation network, giving you access to training and the opportunity to work alongside some of the most skilled validators in the industry. We value your knowledge and expertise and believe that through knowledge sharing, we help each other succeed in both assignments and personal development.

You will join our business area within Compliance & Management, where 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 As a Validation Lead within production, you will lead and drive validation work within Life Science projects of various sizes and complexities. You ensure that processes, systems, and equipment meet regulatory requirements and standards. By working closely with both customers and the internal team, you contribute to high quality across the board.

Your responsibilities will include, but are not limited to:

• Leading and coordinating verification work for equipment, processes, and computer systems.
• Performing risk analyses (FMEA, HACCP) and developing verification strategies.
• Planning, reviewing, creating, and approving verification documentation, including URS, commissioning, DQ, IQ, OQ, and PQ.
• Creating test protocols for verification tests (covering processes, systems, and equipment).
• Ensuring that validation activities meet regulatory requirements (GMP, FDA, ISO standards).
• Collaborating with customers and project teams to ensure timelines and project goals are met.

Qualifications We are looking for you who enjoy leading others, are structured, and communicative in your approach. You enjoy problem-solving and have multiple stakeholder interfaces. We also look for the following:

• A Bachelor's or Master's degree in Biotechnology, Medical Technology, Chemical Engineering, Mechanical Engineering, or equivalent.
• Experience in a validation/qualification role within Life Science production.
• Experience and knowledge of GAMP5 and system classification.
• Good understanding of regulatory requirements and standards such as GMP, EudraLex Volume 4 Annex 15, and ISO 13485.
• Experience in creating and reviewing validation documentation, including URS, DQ, IQ, OQ, and PQ.
• Knowledge of risk analysis methods (e.g., FMEA) and the ability to apply them in practice.
• Fluent proficiency in Swedish and English, both spoken and written.

An exciting journey with Knightec Group Knightec Group is today one of Northern Europe's leading strategic partners in product and digital service development – how cool is that?

By combining engineering competence, digital expertise, and business understanding, we help our customers transform new technology into real solutions that create value. We work at the intersection of business strategy and technology development, supporting our customers throughout the entire journey – from initial ideas to development, implementation, and further evolution.

At Knightec Group, people with different perspectives, experiences, and specialist areas come together. Together, we create innovation that makes a real difference – for businesses, people, and society at large.

For our employees, this means great opportunities to help shape future solutions through meaningful projects at the absolute forefront of technology. Here, you not only develop and grow in your role – you also become part of a team where curiosity, collaboration, and the courage to challenge drive us forward.

Does that sound like the place for you? Join us on our continued journey!

Practical Information This is a permanent position with a six-month probation period, located at our office in Södertälje, Storgatan 41C. Travel to customers may occur as part of the role. Start date is as soon as possible or by agreement.

Submit your application as soon as possible, but no later than 2026-06-28. If you have any questions about the position, you are welcome to contact Kicki Björ, Talent Acquisition Specialist. We handle all applications via our career page to ensure safe and secure processing of your personal data in accordance with GDPR.

We look forward to hearing from you!