Senior Global Microbiology & Sterility Quality Engineer

Datwyler; Alken; Sur place; EUR 110 000 - 140 000; Plein temps

Résumé du poste

Datwyler Healthcare seeks a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to act as the global SME, shaping microbiological quality strategies across our manufacturing network. In this highly visible role, you will influence product quality, regulatory compliance and patient safety on a global scale.

You will lead testing strategies, sterility programs, and environmental monitoring, collaborating with Quality, R&D, Manufacturing, Regulatory Affairs and Operations to

Qualifications

• Master's or PhD in Microbiology or related field.
• 10+ years in pharma/biotech/primary packaging.
• GMP and EU GMP Annex 1 knowledge; sterility expertise.

Responsabilités

• Lead global Contamination Control Strategy per EU GMP Annex 1.
• Drive microbiological risk assessments and contamination prevention.
• Provide leadership on microbiological testing methods (bioburden, endotoxin, sterility).
• Define and oversee environmental monitoring and cleanroom control.
• Develop and maintain sterility assurance for primary packaging.
• Support validation of sterilization, cleaning, and packaging processes.
• Lead investigations, root cause analyses, and CAPA with cross-functional teams.

Connaissances

Microbiology expertise

GMP knowledge

Leadership

Regulatory compliance

Cross-functional collaboration

Formation

Master's degree in Microbiology or related field

PhD (preferred) in Microbiology or related field

Outils

Quality systems

Environmental monitoring

Description du poste

Datwyler Healthcare seeks a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to act as the global SME, shaping microbiological quality strategies across our manufacturing network. In this highly visible role, you will influence product quality, regulatory compliance and patient safety on a global scale.

You will lead testing strategies, sterility programs, and environmental monitoring, collaborating with Quality, R&D, Manufacturing, Regulatory Affairs and Operations to