Validation Engineer

Validation Engineer supports production with technical expertise and ensures regulatory compliance throughout the entire lifecycle of the products.

To ensure the success of the production site in Kaiseraugst, our client progresses through scientific and technical expertise and proactive service. They achieve this through continuous improvement of the processes, agile employees, and passion.

Your Profile:
 

The “ideal candidate” has more than 5 years of GMP experience in the qualification and validation of packaging and assembly equipment as well as related processes. Solid GMP knowledge, a confident approach to regulatory requirements, and experience with inspections are essential. Fluent German and very good English skills complete the profile.

Tasks & Responsibilities:
 

• Processing of change notifications in Veeva
• Execution of process validations and functional tests
• GMP-compliant creation and maintenance of all required work documents

Focus Areas:
 

• Primary Packaging: Tablets & capsules in blisters & bottles
• Secondary Packaging: Vials, FSP, blisters, bottles in folding cartons
• Assembly: Autoinjectors & NSDs (needle safety devices)

Must Haves:
 

• Technical or scientific degree or vocational training with relevant professional experience
• At least 5 years of GMP experience in qualification & validation, ideally with packaging equipment
• Several years of experience in a GMP environment with a deep understanding of quality systems and lean implementation of GMP requirements
• Good knowledge of regulatory requirements and experience with inspections related to packaging and assembly processes
• Hands-on experience with assembly processes and validation of packaging processes (Primary: solid dosage filling in bottles, blisters; Secondary-Tertiary packaging)
• Solid experience in strategic and conceptual work, with strong project management and self-management skills
• Team player
• Highly independent and structured working style, strong initiative, flexibility
• Fluent in German (business level), very good English skills

Nice to haves:
 

• Digital validation (e.g., eVal or Kneat)
• Knowledge of Veeva

Sounds interesting? Apply now – we’re looking forward to receiving your applications!

Application Submission Deadline: 01.07.2025