Vacant job

About Linxens

Linxens is a global leader in micro-connectors, module packaging, antennas & inlays, and secure ID solutions, with over 40 years of innovation. Headquartered in Paris, France, we operate R&D centers and production sites across Germany, France, Sweden, China, India, Singapore, and Thailand.

Our solutions serve industries such as telecommunications, finance, transportation, hospitality, e-government, healthcare, and the Internet of Things (IoT).

Our employees’ expertise and know-how allow us to continually reinvent ourselves and meet our customers’ evolving needs, helping them grow and innovate. Therefore, we invest in developing our employees’ skills and career growth.

Working for Linxens means investing in your future. Our growth is creating great opportunities!

Below is the job description for the open position:

Linxens Sweden AB is a young and modern company that develops and manufactures customized solutions in printing and stamping, with products such as biosensors and stick-to-skin wearables. We are a creative partner offering quality and innovative solutions. We are part of a global group with approximately 2,500 employees, providing us with a stable and growing foundation for the future.

We are now looking for a driven and structured Validation Engineer who wants to contribute to our continued success. The position is located in Ängelholm, and you will report to the R&D and Projects Manager, becoming an important part of our development work in all processes.

Your Role

As a Validation Engineer, you are responsible for validation work by ensuring that our manufacturing processes, machines, and systems are quality-assured (qualified/validated). You lead the validation work in cross-functional teams with production, quality, and project management – always with the customer's needs and regulatory requirements in focus. You have broad experience working in a regulatory environment and with continuous improvements.

You will:

• Plan, lead, and document qualifications/validations and the risk reviews and deviation investigations related to validation. You are also responsible for compiling the results in the reports required by the validation process.
• Ensure that everything is done according to standards (ISO 9001, ISO 13485, CFR 21).
• Coordinate validation efforts together with project managers who are responsible for and have an overview of both internal and customer-driven projects.
• Work closely with customers, suppliers, and internal stakeholders, e.g., the project team, production managers, QA).

We are looking for someone who has:

• Basic knowledge of ISO 9001, ISO 13485, ISO 14001, CFR 21, and GMP.
• A university degree in engineering (mechanical, chemical, medical technology, or similar).
• Several years of experience in qualification/validation in an industrial or medical technology environment, and experience with production technology.
• Good understanding of production technology and quality systems (preferably according to ISO 13485, CFR 21, and/or GMP).
• Experience working in project form, with high tempo and multiple contact surfaces.
• Experience working with Minitab or similar tools.
• Ability to structure, prioritize, and make decisions independently.
• Fluent Swedish and English in speech and writing.
• Experience with automated processes/software validation.
• Experience with international collaborations.

To succeed in the role, we also believe you are:

• Independent, proactive, and responsible.
• Receptive and humble in interactions with colleagues and customers.
• Structured, quality-focused, and interested in administration.
• Team-oriented with a strong customer focus.
• Flexible and service-oriented, with a positive attitude towards both colleagues and customers.
• Proactive, with the ability to suggest and/or drive improvements in processes and working methods.

Join Linxens to work in a multicultural environment, collaborating with leading tech innovators and making a global impact on technology.