Validation Engineer, Life Science

Knightec Group AB

Södertälje, Stockholms län
Vanlig anställning - Heltid - Tills vidare
Fast månads- vecko- eller timlön
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About this role

**Why this job is for you** Here, you will have the opportunity 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 become part of a team of experts in validation, helping our clients achieve safe products and enhanced quality of life for users. Your development will be a priority, and you will have ongoing discussions with your manager about future development opportunities to create a plan that suits you and your ambitions—all aimed at helping you grow and work in assignments and roles where you thrive. You will also be part of our internal networks within validation, giving you access to training and the chance to collaborate with some of the most skilled validators in the industry. We have a strong focus on knowledge sharing and support each other in succeeding in assignments and in our development. You will be part of our business area 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** The core of the role involves validation and qualification of equipment, processes, and computerized systems within the Life Science industry. You may also be involved in design, procurement, and commissioning, allowing you to truly influence results and outcomes. You will either work on our own deliveries to jointly provide a completed project to the client or within our clients' operations. Your responsibilities will include: - Validation/qualification of equipment and systems - Ensuring that the project timeline is adhered to - Coordinating between different functions in the project - Proactively finding solutions to challenges that arise - Leading, coordinating, and writing risk assessments - Leading deviation investigations **Qualifications** To thrive in this role, you have an interest in technology, enjoy working in complex production environments, and appreciate a role with multiple points of contact. You like problem-solving, are attentive, and enjoy learning new things and sharing your knowledge. You also have: - An engineering degree in biotechnology, medical technology, chemical engineering, mechanical engineering, or equivalent - Experience working with validation in Life Science, having been part of some of the SQ/IQ/OQ/PQ phases - Experience in the pharmaceutical industry - Experience in requirements and deviation management - Good knowledge of GxP regulations. Knowledge of GAMP5, 21 CFR part 11, and Eudralex Annex 11 is a plus - Fluent communication skills in Swedish and English **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 possess 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 greater. 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 may be required for client visits. The start date is as soon as possible or by agreement. 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. We handle all applications through our career page to ensure a safe and secure management of your personal data in accordance with GDPR. We look forward to hearing from you!
Civilingenjör, kemiteknik Yrken med teknisk inriktning
Posted 24 Nov 2025 • 1 views

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