Development Engineer - System & Process Engineering | Aseptic Processing Technology
Overview
As a Senior Development Engineer - System & Process Engineering, you take on a central role in the technical leadership of developing innovative, GMP‑compliant solutions for aseptic processing systems such as Fill & Finish and device assembling. In this position, you apply your in-depth understanding of pharmaceutical processes as well as your strong systems thinking to ensure that process requirements, product needs, and system architecture are optimally aligned.
Responsibilities
* Independent development, design, and optimization of aseptic processing systems, considering process, product, and customer requirements
* Derivation and design of robust module and system architectures based on complex technical requirements
* Responsibility for requirements management, including ensuring consistency and traceability
* Definition, coordination, and evaluation of technical interfaces within complex system and plant structures
* Planning and execution of structured risk analyses, including derivation of appropriate measures
* Technical leadership and functional responsibility within subsystems/projects - without disciplinary responsibility
* Ensuring GMP, Annex 1, and compliance conformity throughout system and process development
* Technical consulting and alignment with customers and internal project teams on technical and regulatory topics
Hardskills
* Degree in Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, or comparable
* Several years of experience in the design, development, or engineering of systems in a regulated environment (e.g. pharmaceutical, food, chemical)
* Solid expertise in aseptic manufacturing and Fill & Finish processes
* Confident handling of GMP, Annex 1, and common risk analysis methods
Softskills
* Strong technical, analytical, and systems thinking capabilities
* Structured and independent working style in complex technical projects
* Strong communication skills and confident interaction with internal departments and customers
* Ability to communicate technical topics clearly and develop solutions collaboratively
* Team-oriented in interdisciplinary project environments
* Willingness and ability to take technical responsibility - even without disciplinary leadership
* Ability to systematically analyze problems and develop sustainable, technically sound solutions
We offer you
* An open and collaborative company culture
* Freedom to contribute ideas in demanding engineering projects
* Professional and personal development
* Structured and practice-oriented onboarding
* Flat hierarchies and short decision-making processes
* Transparent and direct communication across all levels
* Attractive sports and leisure activities
* 5 weeks of vacation and the option to purchase additional vacation days
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