Senior Global Microbiology & Sterility Quality Engineer

Datwyler Group; Alken; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Datwyler Healthcare seeks a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to lead global microbiology quality strategies across our manufacturing network. You will drive sterility assurance programs, contamination control, and testing strategies while partnering with Quality, R&D, Manufacturing, Regulatory Affairs, and Operations.

The role requires a Master’s or PhD in a related field, 10+ years of relevant experience, expertise in GMP compliance, and excellent

Qualifications

• Master's or PhD in a relevant scientific discipline with advanced microbiology expertise.
• Minimum 10 years of experience in pharma/biotech/medical device packaging.
• 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.
• Proven ability to provide scientific leadership across a global organization.
• Excellent communication and collaboration skills.
• Fluent in English.

Responsabilités

• Lead and continuously improve the global Contamination Control Strategy in line with EU GMP Annex 1.
• Drive microbiological risk assessments and define 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

Fluent English

Communication skills

Collaboration skills

Leadership

Formation

Master's degree or PhD in Microbiology, Biotechnology, Pharmaceutical Sciences, Biomedical Engineering, or related field

Description du poste

Datwyler Healthcare seeks a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to lead global microbiology quality strategies across our manufacturing network. You will drive sterility assurance programs, contamination control, and testing strategies while partnering with Quality, R&D, Manufacturing, Regulatory Affairs, and Operations.

The role requires a Master’s or PhD in a related field, 10+ years of relevant experience, expertise in GMP compliance, and excellent