Director of Microbiology & Contamination Control (GMP)

3M HEALTHCARE; Ireland; A distancia; EUR 180.000 - 230.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in Ireland seeks a Director of Quality (Contamination Control and Microbial Excellence) to lead global contamination control strategies and microbiology excellence across PSG sites, ensuring GMP compliance with Annex 1 and FDA guidelines.

You will collaborate with Operations, MSAT, Engineering and quality teams to define policies, drive CAPAs, and support inspections while advancing digitalization across PSG sites.

Formación

• Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or related field.

Responsabilidades

• Support site CCME colleagues to develop, implement, and maintain site contamination control strategies based on risk assessments.
• Provide SME in microbiology, microbiological methods, contamination control, aseptic processing, EM, cleanroom design, cleaning and disinfection.
• Support global review of EM trends and remediation of adverse trends in all cleanrooms.
• Provide above-site support for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance.
• Support CAPA plan definition, preventive measures and continuous improvement initiatives.
• Provide above-site support for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance.
• Provide guidance during facility and process design, including design-led contamination controls and material/personnel and waste flows.
• Provide SME input into qualification of manufacturing equipment and cleanroom that impact CCME, including sterilization processes.
• Inspection Readiness.
• Support digitalization and innovation across PSG sites.

Conocimientos

Effective communicator

Cross-functional collaboration

Regulatory knowledge

Educación

Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or related field

Descripción del empleo

Thermo Fisher Scientific in Ireland seeks a Director of Quality (Contamination Control and Microbial Excellence) to lead global contamination control strategies and microbiology excellence across PSG sites, ensuring GMP compliance with Annex 1 and FDA guidelines.

You will collaborate with Operations, MSAT, Engineering and quality teams to define policies, drive CAPAs, and support inspections while advancing digitalization across PSG sites.