As a Senior Qualification Engineer, you will play a key role in establishing and qualifying new device assembly capabilities for combination products (e.g. autoinjectors, needle safety systems, wearable infusion devices) within a GMP-regulated environment. 
You will be responsible for the full qualification lifecycle of new assembly lines, cleanrooms, utilities, and equipment, ensuring all systems are compliant with regulatory expectations and fit-for-purpose for GMP production. 
This is a unique opportunity to contribute to the build-up of a new, state-of-the-art device assembly line(s)— from equipment onboarding to process validation and routine manufacturing.

Your responsibilities include,

• Lead the planning, execution, and documentation of qualification activities (DQ, IQ, OQ, PQ) for new device assembly equipment, infrastructure, and supporting systems
• Support installation and startup of new equipment, including FATs (Factory Acceptance Tests) and SATs (Site Acceptance Tests)
• Collaborate with the device assembly project team, including QA, Engineering, MSAT, and Production, to define qualification strategies aligned with device-specific regulatory requirement, driving technical execution from design through to operational readiness.
• Contribute to the development of scalable, compliant qualification processes tailored to combination product manufacturing. Ensure readiness of device assembly lines for GMP-compliant production, supporting end-to-end qualification and validation
• Provide expert input during deviation investigations, change controls, and process-related troubleshooting in qualification scope
• Represent qualification topics during internal and external audits and regulatory inspections
• Actively contribute to the development of the site's overall qualification strategy

We are looking for someone with, 

• Degree in engineering or a technical/scientific discipline; further technical training a plus
• Minimum 5 years of experience in qualification within a GMP-regulated or medical device environment
• Proven experience with automated device assembly systems, including equipment qualification and process validation 
• Familiar with combination product regulations (e.g. EU MDR, FDA 21 CFR Part 4/820) and their application in qualification and validation
• Strong understanding of cleanroom classification, aseptic processing, and associated utilities (e.g. HVAC, compressed air) 
• Highly organized, detail-oriented, and experienced in managing multiple technical projects simultaneously 
• Fluent in English (written and spoken); German is a strong advantage
• Proactive, hands-on mindset with the ability to work in a dynamic and evolving environment

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
 
Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment  
• Flexible working arrangements and environment with an open culture and diverse workforce  
• The opportunity to work with and learn from highly qualified and experienced employees  
• Our learning and self-developing culture offers a wide range of training options  
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit 

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.

For more information and clarification, please connect with Amrith (amrith.kiran@ten23.health) from our Talent team!