QC Microbiology Technician: GMP Sterility & Bioburden Lead

Incyte

Yverdon-les-Bains

Presencial

CHF 90.000 - 120.000

Jornada completa

Hace 4 días

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Descripción de la vacante

Incyte in Yverdon-les-Bains, Switzerland, invites applications for a QC Microbiology Technician to support production release of drug substances and products. You will perform microbiology testing (Bioburden, LAL), sterility testing in an isolator, and environmental monitoring in a GMP environment, with data review and documentation, SOP drafting, and participation in CAPA investigations.

We seek a degree in Microbiology with 5+ years in biotech/pharma, hands-on Sterility testing experience, and

Formación

Degree in Microbiology (CFC or higher) with at least 5 years in biotech/pharma
Proven hands-on Bioburden and LAL testing experience in GMP
Experience with sterility testing of DP using an isolator in GMP

Responsabilidades

Performs QC analysis to support production release of drug substance (Bioburden, LAL).
Performs sterility testing of aseptically filled drug product (DP) using an isolator.
Performs sampling and testing for environmental monitoring and utilities control.
Ensures adherence to GMP, data integrity requirements, safety rules, and internal quality standards.
Executes microbiology method verification/validation activities (Bioburden/LAL and related methods).
Perform thorough review of analytical raw data, calculations, records and reports, including second-person review.