Role Overview
We are seeking a Development Engineer to support the design and development of an innovative drug substance handling device for continuous processing. This role is pivotal in advancing aseptic manufacturing technologies and automation and will contribute to both early- and late-phase platform development.
The position will work independently and in collaboration with Manufacturing, Development, and Quality teams, as well as external partners and suppliers.
Key Responsibilities
* Design, develop, and test a novel device for drug substance handling in continuous operations.
* Lead product and process development activities, including technology transfer and control strategy development.
* Collaborate with cross-functional teams (Process Development, Automation, Quality, Regulatory Affairs).
* Translate user and process requirements into technical specifications and design concepts.
* Conduct risk assessments, design reviews, and support qualification/validation activities.
* Interface with suppliers and external partners for technical development and sourcing.
* Ensure all documentation is GMP- and ISO-compliant.
* Prepare technical reports and present findings to peers and management.
Key Requirements
* Bachelor’s or Master’s degree in Engineering (Biomedical, Bioengineering, Chemical, Electrical, Mechanical) or related field.
* 3+ years’ experience in device development or qualification (pharmaceutical or medical device industry preferred).
* Strong understanding of fluid dynamics, data processing (PI System), and automation.
* Proficiency in CAD software (SolidWorks, Creo, or similar).
* Fluent in German and English (C1 minimum).
* Solid knowledge of GMP regulations and ISO standards.
* Strong analytical mindset, effective communicator, and proven ability to work within matrix/cross-functional teams.
What We Offer
* Opportunity to contribute to a cutting-edge development project with direct impact on manufacturing efficiency and product safety.
* A supportive, dynamic, and collaborative team culture.
* Competitive compensation and benefits package.
* Professional development and career growth opportunities within a global network.
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