Global Senior Quality Engineer - Microbiology & Sterility

Datwyler Group; Alken; Hybride; EUR 90 000 - 140 000; Plein temps

Avantages offerts par ce poste

Attractive compensation

Hybrid work

Learning & development

Cutting-edge tech

Collaborative team

Résumé du poste

Datwyler is seeking a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to strengthen our global Quality organization. In this highly visible role, you will act as the SME shaping microbiological quality, sterility strategies, and contamination control across our manufacturing network.

This role offers leadership in microbiology testing, bioburden and endotoxin assessment, and collaboration with Quality, R&D, Regulatory Affairs and Operations to ensure regulatory

Qualifications

• Master’s degree or PhD in Microbiology, Biotechnology, Pharmaceutical Sciences, Biomedical Engineering or a related scientific discipline.
• Minimum 10 years of experience in the pharmaceutical, biotechnology, medical device or primary packaging industry.
• Strong expertise in sterile manufacturing, sterility assurance, contamination control and process validation.
• Solid understanding of GMP requirements including EU GMP Annex 1 and Quality Risk Management principles.
• Proven ability to provide scientific leadership and influence stakeholders across a global organization.
• Excellent communication and collaboration skills.
• Fluent in English, any other language is a plus.

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.

Description du poste

Datwyler is seeking a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to strengthen our global Quality organization. In this highly visible role, you will act as the SME shaping microbiological quality, sterility strategies, and contamination control across our manufacturing network.

This role offers leadership in microbiology testing, bioburden and endotoxin assessment, and collaboration with Quality, R&D, Regulatory Affairs and Operations to ensure regulatory