Technician QC Microbiology

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

Zusammenfassung

Incyte in Yverdon-les-Bains, Switzerland, seeks a QC Microbiology Technician to support production release and sterility testing using an isolator. You will perform Bioburden, LAL testing, environmental monitoring, and contribute to method verification/validation within a GMP environment.

You will review data, maintain SOPs, drive continuous improvement, and collaborate with QA, Engineering and Validation. French fluent and English good, 5+ years in biotech QC preferred.

Qualifikationen

• 5+ years in biotech/pharmaceutical QC microbiology in GMP setting.
• Hands-on Bioburden and LAL testing experience.
• Experience with sterility testing using an isolator.
• Knowledge of GMP data integrity principles.
• Strong cross-functional collaboration and communication.

Aufgaben

• Performs QC analysis to support production release of drug substance (Bioburden, LAL).
• Performs sterility testing of aseptically filled drug product using an isolator for DP batch release.
• Performs sampling and testing for environmental monitoring and utilities control.
• Ensures adherence to GMP, data integrity, safety, and internal quality standards.
• Executes microbiology method verification/validation activities.

Kenntnisse

Bioburden

LAL

Sterility testing

Environmental monitoring

Data integrity

CAPA

GMP documentation

Cross-functional collaboration

Process optimization

Digitalization

Ausbildung

Microbiology degree (CFC or higher)

Tools

Isolator

LIMS

Jobbeschreibung

Summary

The QC Microbiology Technician performs microbiology activities to support production and release of drug substance and drug product, including sterility testing of aseptically filled drug product (DP) using an isolator, as well as environmental and utilities monitoring and control in a GMP environment. In addition to routine testing, the QC Microbiology Technician contributes to microbiology method verifications/validations (e.g., Bioburden, LAL), performs review of data and documentation, and actively contributes to continuous improvement, laboratory automation initiatives, and laboratory investigations including root cause analysis. He/she also authors and maintains analytical and QC procedures and provides technical support to other team members.

Aperçu

The QC Microbiology Technician performs microbiology activities to support production and release of drug substance and drug product, including sterility testing of aseptically filled drug product (DP) using an isolator, as well as environmental and utilities monitoring and control in a GMP environment. In addition to routine testing, the QC Microbiology Technician contributes to microbiology method verifications/validations (e.g., Bioburden, LAL), performs review of data and documentation, and actively contributes to continuous improvement, laboratory automation initiatives, and laboratory investigations including root cause analysis. He/she also authors and maintains analytical and QC procedures and provides technical support to other team members.

Key Responsibilities

• Performs QC analysis to support production release of drug substance (Bioburden, LAL), ensuring right-first-time execution and documentation.
• Performs sterility testing of aseptically filled drug product (DP) using an isolator to support DP batch release, ensuring compliant aseptic manipulations, right-first-time execution, and accurate GMP documentation.
• Performs sampling and testing for environmental monitoring and utilities control (PV, PNV, Bioburden, LAL, TOC), including scheduling and prioritization when needed.
• Ensures adherence to GMP, data integrity requirements, safety rules, and internal quality standards.
• Executes microbiology method verification/validation activities (Bioburden/LAL and related methods): preparation, execution, documentation, and closure.
• Perform thorough review of analytical raw data, calculations, records and reports, including second-person review as applicable, ensuring completeness, traceability, data integrity, compliance, and timely reporting of results. Contributes actively to laboratory investigations, including structured root cause analysis and definition of robust CAPAs.
• Collaborates cross-functionally (Production, QA, Engineering, Validation, other QC functions) to support investigations and prevention of recurrence.
• Participates in improvement projects to increase lab efficiency, quality, and compliance.
• Contributes to laboratory digitalization/automation initiatives.
• Authors, reviews and maintains SOPs, Work Instructions, and other QC documentation.
• Supports change control activities related to methods/equipment/procedures.
• Supports management of QC consumables, reagents and standards.
• Supports maintenance/calibration of equipment.
• Acts as a role model for GMP behaviors, data integrity, and business ethics.

Education And Experience

• Degree in Microbiology (CFC or higher degree) with at least 5 years of experience in biotech, pharmaceutical environment, including QC Microbiology in a GMP setting.
• Proven hands-on experience with Bioburden and LAL testing, environmental monitoring and utilities control.
• Proven hands-on experience in sterility testing of aseptically filled drug product (DP) using an isolator, including aseptic manipulations, isolator operation, and associated GMP documentation.
• Strong knowledge of microbiology testing in GMP and of method verification/validation/transfer principles.
• Experience in data review (raw data, logbooks, calculations, reports) and in applying data integrity principles.
• Experience supporting deviation investigations, root cause analysis, and CAPA implementation.
• High autonomy and accountability; able to prioritize, anticipate issues, and propose solutions.
• Force of proposal / continuous improvement mindset; comfortable driving improvements and supporting automation/digitalization.
• Excellent team spirit and communication; able to collaborate cross-functionally.
• French: Native or Fluent
• English: Good knowledge
• Knowledge of most common office software.

Work conditions

• Work on weekends and outside standard working hours may be required.