Senior QC Microbiology Technician – GMP

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Incyte Corporation in Switzerland (Waadt, Yverdon-les-Bains) is seeking a QC Microbiology Technician to support production release, sterility testing using an isolator, and environmental monitoring within a GMP environment.

You will review analytical data, contribute to method verifications/validations, and actively participate in continuous improvement, automation initiatives, and investigations to ensure quality and compliance.

Qualifikationen

• Degree in Microbiology (CFC or higher) with 5+ years in biotech/pharma including GMP QC.
• Hands-on Bioburden and LAL testing experience.
• Experience in sterility testing of DP using an isolator and GMP documentation.
• Strong knowledge of GMP microbiology, method verification/validation/transfer.
• Experience in data review, data integrity and CAPA implementation.

Aufgaben

• Performs QC analysis to support production release of drug substance (Bioburden, LAL) with right-first-time execution and documentation.
• Performs sterility testing of aseptically filled drug product using an isolator to support DP batch release with compliant aseptic manipulations and GMP documentation.
• Performs environmental monitoring and utilities control sampling/testing (PV, PNV, Bioburden, LAL, TOC) with scheduling when needed.
• Ensures adherence to GMP, data integrity, safety rules and internal quality standards.
• Executes microbiology method verification/validation activities (Bioburden/LAL).

Kenntnisse

Bioburden testing

LAL testing

Sterility testing

Data review

CAPA implementation

Root cause analysis

Lab automation

Documentation & SOPs

Cross-functional collaboration

Problem solving

Communication

French language

English language

Ausbildung

Bachelor/Master in Microbiology

Tools

MS Office

Jobbeschreibung

Incyte Corporation in Switzerland (Waadt, Yverdon-les-Bains) is seeking a QC Microbiology Technician to support production release, sterility testing using an isolator, and environmental monitoring within a GMP environment.

You will review analytical data, contribute to method verifications/validations, and actively participate in continuous improvement, automation initiatives, and investigations to ensure quality and compliance.