Senior Quality Engineer - Microbiology & Contamination

Datwyler; Belgique; À distance; EUR 95 000 - 150 000; Plein temps

Avantages offerts par ce poste

Direct impact on patient safety

Global exposure and influence

Innovative healthcare environment

Collaboration with international teams

Development opportunities and training

Résumé du poste

Datwyler Healthcare is seeking a Senior Quality Engineer specializing in Microbiology, Sterility & Contamination Control to drive global microbiological quality strategies. You will lead sterility assurance programs across manufacturing, validation, and regulatory compliance in a highly regulated healthcare environment.

In this global SME role, you will influence product quality and patient safety, collaborating with Quality, R&D, Manufacturing, Engineering, Regulatory Affairs, and Operations to

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

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

Sterile manufacturing

Sterility assurance

Contamination control

Process validation

Communication skills

Scientific leadership

Formation

Master's or PhD in Microbiology/Biotechnology/Pharmaceutical Sciences

Description du poste

Datwyler Healthcare is seeking a Senior Quality Engineer specializing in Microbiology, Sterility & Contamination Control to drive global microbiological quality strategies. You will lead sterility assurance programs across manufacturing, validation, and regulatory compliance in a highly regulated healthcare environment.

In this global SME role, you will influence product quality and patient safety, collaborating with Quality, R&D, Manufacturing, Engineering, Regulatory Affairs, and Operations to