Senior Microbiology QC Engineer – Sterility & Contamination

Datwyler Group; Pregnana Milanese; Ibrido; EUR 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work options

Continuous learning

Development opportunities

Descrizione del lavoro

Datwyler Group in Italy is seeking a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to shape microbiological quality across the manufacturing network. You will lead testing programs, drive sterility assurance, and manage contamination control as part of global QA initiatives.

The role requires a PhD or MSc with 10+ years experience, strong GMP knowledge, and leadership in a multinational environment.

Competenze

• 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.

Mansioni

• Lead global Contamination Control Strategy (CCS) aligned with EU GMP Annex 1.
• Drive microbiological risk assessments and define contamination prevention measures.
• Provide technical leadership on microbiological testing (bioburden, endotoxin, sterility).
• Define environmental monitoring and cleanroom control across sites.
• Develop global sterility assurance approaches for primary packaging components.
• Support validation of sterilization, cleaning, washing, and packaging processes.
• Lead complex microbiological investigations and CAPA activities.
• Collaborate with cross-functional teams to improve quality and compliance.

Conoscenze

Microbiology

Sterility

Contamination control

Process validation

GMP knowledge

Regulatory knowledge

Technical leadership

English fluency

Formazione

Master's degree in Microbiology

PhD in related field

Descrizione del lavoro

Datwyler Group in Italy is seeking a Senior Quality Engineer – Microbiology, Sterility & Contamination Control to shape microbiological quality across the manufacturing network. You will lead testing programs, drive sterility assurance, and manage contamination control as part of global QA initiatives.

The role requires a PhD or MSc with 10+ years experience, strong GMP knowledge, and leadership in a multinational environment.