We are seeking a Qualification Engineer Automation Systems & Special Machines to ensure the quality and compliance of our advanced, automated assembly systems built for the highly regulated Pharmaceutical and Medical Device industries. This is a critical role that acts as the primary quality assurance expert, bridging technical engineering with stringent regulatory requirements.
Key Responsibilities
* Validation Management: Lead the complete qualification and validation lifecycle for automated systems (including mechanical, software, and hardware components).
* Documentation & Standards: Prepare, structure, and maintain all required qualification/validation documentation, adhering to GxP standards.
* Testing Leadership: Plan, execute, and oversee formal testing activities, including FAT (Factory Acceptance Tests) and SAT (Site Acceptance Tests), internally and at customer locations.
* Compliance & Risk: Conduct risk analyses, identify non-conformities, propose corrective actions, and ensure all systems comply with medical and pharmaceutical industry guidelines.
* Collaboration: Act as the central technical contact for qualification, collaborating closely with design teams, external partners, and clients.
Required Skills & Experience
* Engineering degree in Mechanics, Automation, or a related field.
* Proven, hands‑on experience in the qualification and validation of complex automated machinery.
* Strong knowledge of regulatory standards and validation processes in a regulated environment (e.g., medical device or pharma).
* Methodological rigor, excellent analytical skills, and a collaborative team approach.
* Proficiency in Swiss German is required for communication with local clients and teams.
Seniority level
* Associate
3>Employment type
* Full-time
Job function
* Manufacturing
* Quality Assurance
* Product Management
Industries
* Automation Machinery Manufacturing
* Industrial Machinery Manufacturing
* Machinery Manufacturing
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