As a MSAT/Production Expert for Device Manufacturing & Assembly, you will play a key technical role in the establishment and scale-up of new device assembly capabilities for combination products (e.g. prefilled syringes with needle safety devices, autoinjectors, wearable delivery systems). 
 You will be responsible for the technical process implementation and readiness of new device assembly lines, ensuring that all equipment and processes are fit-for-purpose, GMP-compliant, and aligned with regulatory and process performance requirements.
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 role will include, 

• Lead and shape the technical design, definition, and ramp-up of new device assembly processes for combination products (e.g. autoinjectors, PFS/NSDs, wearable infusion devices) 
• Drive the establishment of new device assembly capabilities, including support for equipment specification, installation, commissioning, and process definition in close collaboration with the cross-functional project team.
• Ensure successful technology transfer, device-related process development, PPQ, risk assessments and technical troubleshooting for new assembly lines in a GMP-compliant environment.
• Define, standardize, and implement production procedures, work instructions, and training concepts for device handling, assembly, in-line testing, and packaging for combination products (autoinjectors, needle safety devices, infusion dev ices)
• Provide technical support during deviation investigations, CAPAs, and change controls

We are looking for someone with, 

• Master’s degree in a Life Science or Engineering discipline (e.g. Medical Device Engineering, Pharmaceutical Technology, Biotechnology, Biochemistry)
• Minimum 3 years of hands-on experience in sterile manufacturing or MSAT, with proven involvement in device assembly processes — ideally in combination product environments (e.g. prefilled syringes/NSD, autoinjectors, wearable deliverable devices)
• Strong technical expertise in device assembly technologies, component compatibility, and integration of drug products into final delivery systems. Hands-on experience in setting up new manufacturing capabilities is an asset. 
• Proven expertise in the integration of medical devices into aseptic drug product processes, including design transfer, component compatibility, and device assembly under GMP.  
• Sound understanding of combination product regulations (EU MDR, FDA 21 CFR Part 4/820) and GMP compliance in cross-regulated environments 
• Open mindset with a proactive, “builder” attitude — excited to help shape and scale a new Device Assembly platform within a complex sterile manufacturing setting 
• Excellent communication skills and experience working in cross-functional teams
• Fluent in English; German is a plus
• Willingness to work on-site regularly and during production campaigns

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!