Senior Engineer, Primary Packaging Material and Device Testing (f/m/d) 80-100%

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.  
 
We are looking for a Senior Engineer, Primary Packaging Material and Device Testing to support our Basel team... 
 
Your responsibilities will include,   

• Lead and/or support internal and customer device and primary packaging projects across ten23’s Basel Development Operations and Visp GMP Manufacturing Operations with notable cross-functional interaction  
• Support the buildup, development and maintenance of strategies, structures, systems and equipment including its qualification and processes enabling device assembly, primary packaging material testing.
• Collaborate with equipment vendors, device and packaging material suppliers
• Author procedures, design control and risk management documentation  
• The role will be part of our Operations Circle with primary place of employment being Basel with frequent on-site presence required at ten23’s Visp site 

We are looking for someone with: 

• Professional experience in primary packaging materials, combination products and medical devices for biopharmaceutical applications (e.g. prefilled syringes with needle safety devices, autoinjectors) for clinical and commercial sterile drug products, preferably with a primary packaging and medical device supplier, contract manufacturing organization or pharmaceutical company
• Expertise in one or more technical areas such as primary packaging material testing, design controls and device development, process engineering, assembly, quality risk management, process performance qualification in accordance with the applicable standards and regulations (e.g. ISO 13485, 21 CFR 820, EU MDR, cGMPs)
• Technical leadership and project management skills
• Quality as well as growth mindset with sound business acumen, ‘patient first’ mentality, good communicator and team player, self-organized, self-prioritizing and self-responsible, thinking creatively and acting out of the box
• University level education (mechanical engineering degree or related discipline) 

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 ([email protected]) from our Talent team!