Senior Microbiology Quality Engineer, Sterility

Datwyler; Alken; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Attractive compensation

Hybrid work options

Learning & development

Cutting-edge technologies

Collaborative environment

Résumé du poste

Datwyler is seeking a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to shape and advance microbiological quality across its manufacturing network. This global SME will drive sterility assurance programs, environmental monitoring, and complex investigations, collaborating with Quality, R&D, Manufacturing, Regulatory Affairs, and Operations.

The role emphasizes leadership, regulatory compliance, and the continuous improvement of contamination control strategies across

Qualifications

• Master's degree or PhD in Microbiology or related field.
• 10+ years in pharma/biotech/medical devices.
• Expert in sterile manufacturing, sterility assurance, and contamination control.
• Strong GMP knowledge including EU Annex 1.
• Proven scientific leadership and cross-functional influence.
• Excellent communication and collaboration; fluent in English.

Responsabilités

• Lead and continuously improve Datwyler Healthcare's global Contamination Control Strategy (CCS) in line with EU GMP Annex 1 requirements.
• Drive microbiological risk assessments and define effective contamination prevention measures.
• Provide technical leadership on microbiological testing, including bioburden, endotoxin, and sterility-related methods.
• Define and oversee environmental monitoring and cleanroom control strategies across manufacturing sites.
• Develop and maintain global sterility assurance approaches for pharmaceutical primary packaging components.
• Support validation of sterilization, cleaning, washing, and packaging processes.
• Lead complex microbiological investigations, root cause analyses, and CAPA activities.
• Partner with cross-functional teams to drive quality improvements and ensure regulatory compliance.

Connaissances

GMP knowledge

Communication skills

Cross-functional collaboration

English fluent

Formation

Master's or PhD in Microbiology

Outils

Sterility testing equipment

Description du poste

Datwyler is seeking a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to shape and advance microbiological quality across its manufacturing network. This global SME will drive sterility assurance programs, environmental monitoring, and complex investigations, collaborating with Quality, R&D, Manufacturing, Regulatory Affairs, and Operations.

The role emphasizes leadership, regulatory compliance, and the continuous improvement of contamination control strategies across