Qualification Engineer Automation Systems

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.

• 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.

• 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.

• Associate

• Full-time

• Manufacturing
• Quality Assurance
• Product Management

• Automation Machinery Manufacturing
• Industrial Machinery Manufacturing
• Machinery Manufacturing