Senior Microbiologist - Sterile Injectables

Actalent; Florida; Presencial; USD 85 000 - 120 000; Tempo integral

Resumo da oferta

Actalent invites a skilled Microbiologist to join our pharma manufacturing team. You will perform environmental monitoring, sterility and bioburden testing, and water system analysis in a sterile injectable environment.

Collaborating with Quality, Manufacturing, Engineering, and Validation, you will investigate deviations and support CAPAs while maintaining ALCOA+ data integrity across lab documentation.

Qualificações

• Bachelor's degree in Microbiology or related field.
• 5+ years of pharmaceutical microbiology experience.
• Experience in sterile injectable manufacturing environment is required.
• Experience supporting regulatory inspections and audits is preferred.
• Strong knowledge of FDA cGMP and data integrity principles.

Responsabilidades

• Perform environmental monitoring in cleanrooms and controlled areas.
• Conduct water system testing and sterility/bioburden analyses.
• Investigate contamination events and participate in CAPA.
• Maintain validation and instrument qualification activities.
• Prepare documentation following ALCOA+ data integrity standards.

Conhecimentos

Pharmaceutical microbiology

Sterile manufacturing

Regulatory inspections

Quality systems

ALCOA+ data integrity

CAPA investigations

Formação académica

Bachelor's degree in Microbiology or related field

Ferramentas

Laboratory equipment

Descrição da oferta de emprego

Actalent invites a skilled Microbiologist to join our pharma manufacturing team. You will perform environmental monitoring, sterility and bioburden testing, and water system analysis in a sterile injectable environment.

Collaborating with Quality, Manufacturing, Engineering, and Validation, you will investigate deviations and support CAPAs while maintaining ALCOA+ data integrity across lab documentation.