Senior Microbiologist - Onsite EtO & Sterilization Expert

4220 embecta Penel Irish Branch; Dún Laoghaire; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

embecta is seeking a Senior Microbiologist for its Dun Laoghaire manufacturing site. You will serve as the microbiology SME for EtO sterilization, GLP labs, and cleanroom standards, ensuring products meet regulatory and company requirements in a hands-on role.

You will collaborate with Quality and Manufacturing teams to maintain inspection readiness and drive compliant outcomes in a highly regulated environment. Onsite work is required given laboratory and cleanroom activities.

Qualifikationen

• Degree in Microbiology or related Science.
• 5+ years in medical device, pharma, or biotech.
• Strong GLP, cleanrooms, validation, and sterilization expertise.
• EtO sterilization experience is advantageous.

Aufgaben

• SME oversight for EtO sterilization, GLP labs, and environmental monitoring.
• Review/approve sterilization cycles, microbiological data, and product release.
• Set microbiological and sterilization quality standards and ensure consistency.
• Ensure ISO 11135, ISO 10993, ISO 13485, FDA QSR/QMSR compliance.
• Lead investigations, CAPA, and non-conformance resolution.
• Maintain lab safety, equipment readiness, and data integrity expectations.
• Maintain audit and inspection readiness.

Kenntnisse

Microbiology expertise

Sterilization

Regulatory compliance

Cleanroom procedures

Ausbildung

Degree in Microbiology or related Science

Tools

EtO sterilization equipment

Jobbeschreibung

embecta is seeking a Senior Microbiologist for its Dun Laoghaire manufacturing site. You will serve as the microbiology SME for EtO sterilization, GLP labs, and cleanroom standards, ensuring products meet regulatory and company requirements in a hands-on role.

You will collaborate with Quality and Manufacturing teams to maintain inspection readiness and drive compliant outcomes in a highly regulated environment. Onsite work is required given laboratory and cleanroom activities.