Validation Leader, Life Science

**Why this job is for you** You want to make a real difference as a consultant in Life Science. Together with our clients, we contribute to improving people's lives and quality of life by developing production, quality, and project operations. You will be part of a team of experts in validation, helping our clients 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 about future development opportunities to shape a plan that suits you and your ambitions—everything 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, which gives 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 in helping each other succeed in both assignments and development through knowledge sharing. You will be part of our business area within Compliance & Management, where we support an efficient transition to digital, sustainable, and safe solutions through expert knowledge in areas such as quality, safety, sustainability, and project management. **Responsibilities** As a Validation Lead, you will lead and drive validation work within Life Science projects of various sizes and complexities. You will ensure that processes, systems, and equipment meet regulatory requirements and standards. By working closely with both clients and the internal team, you will contribute to high quality at every level. Your responsibilities will include: - Leading and coordinating validation work for equipment, processes, and computer systems - Planning, reviewing, creating, and approving validation documentation, including URS, DQ, IQ, OQ, and PQ - Ensuring that validation activities meet regulatory requirements (GMP, FDA, ISO standards) - Collaborating with clients and project teams to ensure timelines and project goals are met - Conducting risk analyses (FMEA, HACCP) and developing validation strategies **Qualifications** We are looking for someone who enjoys leading others and is structured and communicative in their work approach. You like problem-solving and having multiple points of contact. We also see that you have: - An engineering degree in biotechnology, medical technology, chemical engineering, mechanical engineering, or equivalent - Experience in a role related to validation/qualification within Life Science - Good knowledge 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 in Swedish and English, both spoken and written **An exciting journey with Knightec Group** Semcon and Knightec have merged to form Knightec Group. Together, we are Northern Europe's leading strategic partner in product and digital service development—how exciting 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 tackle 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 Södertälje, Storgatan 41C. Travel for work may occur to our clients. Start date is to be agreed upon. Please submit your application as soon as possible, but no later than December 19, 2025. If you have any questions about the position, feel free to contact Lina Orfanidou, Talent Acquisition Partner. Please note that, due to GDPR, we only accept applications via our career page. We look forward to hearing from you!