Vacant job

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 be part of a team of experts in validation, helping our clients achieve safe products and enhanced quality of life for users. Here, you and your development are in focus; you will have continuous dialogue with your manager about 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. You will be part of our internal networks in validation, giving you access to training and the opportunity to work alongside some of the most skilled validators in the industry. We have a strong focus on knowledge sharing and support each other to succeed in assignments and in our development.

You will be part of our business area Compliance & Management, where we support an effective transition to digital, sustainable, and safe solutions through expert knowledge in areas such as quality, safety, sustainability, and project management. Job Responsibilities The core of the role is validation and qualification of equipment, processes, and computerized systems within the Life Science industry. You will also be involved in design, procurement, and commissioning, allowing you to truly influence results and outcomes. You will either work in our own deliveries to jointly deliver a completed project to the client or in our clients' operations. Your responsibilities include:

• Validation/qualification of equipment and systems
• Ensuring the project timeline is maintained
• Coordination between different functions in the project
• Being proactive in 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, and you enjoy working in complex production environments with multiple points of contact. You like problem-solving, are attentive, and enjoy learning new things and sharing your knowledge. You also have:

• Engineering degree in biotechnology, medical technology, chemical engineering, mechanical engineering, or equivalent
• Experience working with validation within 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
• You communicate fluently in Swedish and English

An exciting journey with Knightec Group Semcon and Knightec have merged to form Knightec Group. Together, we are the leading strategic partner in Northern Europe for 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 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 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 for work may occur to our clients. The start date is as soon as possible or by agreement.

Please submit your application as soon as possible, but no later than 2025-12-19. If you have any questions about the position, please contact Lina Orfanidou, Talent Acquisition Partner. We handle all applications through our career page to ensure safe and secure handling of your personal data in accordance with GDPR.

We look forward to hearing from you!