Validation Engineer (Global External Manufacturing)

About the role

We are seeking a Validation Engineer for Global External Manufacturing to act as a quality partner, auditor, supplier developer and technical expert. You will lead qualification and validation activities with our external suppliers, ensuring compliance with regulatory standards and high‑quality production.

Key responsibilities

• Review and evaluate qualification and validation documents and process risk analyses supplied by external manufacturers.
• Oversee deviation assessments related to qualification and validation, ensuring rigorous standards are met.
• Document evaluation outcomes in accordance with established quality procedures.
• Support continuous improvement by providing technical advice and performing statistical data analyses.
• Advise suppliers on quality and compliance matters, covering relevant standards and specifications.
• Collaborate across departments and within squads to achieve common quality goals.

Required profile

• Bachelor’s degree in engineering, scientific or technical field, or equivalent experience.
• Minimum 10 years of experience in quality functions (Q&V, auditing) within the pharma or medical‑device industry.
• At least 5 years of experience with external manufacturing, including automated production technologies such as injection and blow molding.
• Strong knowledge of IVDR, MDR, ISO 13485 and 21 CFR 820 regulations.
• Professional fluency in English and German.

Required skills

• IVDR compliance
• MDR compliance
• ISO 13485
• 21 CFR 820
• Process risk analysis
• Statistical data analysis
• Injection molding technology
• Blow molding technology

What we offer

• 12‑month fixed‑term contract with possible extension.
• Workplace in Rotkreuz with hybrid work mode (remote possible, limited travel).
• Opportunity to work with a world‑leading in‑vitro diagnostics company.