Lead QA Engineer — Equipment Qualification & CSV

Incyte Corporation; Yverdon-les-Bains; Presencial; CHF 110.000 - 150.000; Jornada completa

Descripción de la vacante

Incyte Corporation is seeking a QA Oversight professional to support QA for engineering and CSV activities at a large-scale biopharmaceutical manufacturing site in Yverdon-les-Bains, Switzerland.

The role focuses on ensuring qualification, validation and data integrity across equipment lifecycle, reviews of documentation, and collaboration with Engineering, Manufacturing and Validation to drive quality and compliance.

Formación

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
• Minimum 5 years in an Engineering/CSV role with QA experience.
• Thorough knowledge of cGMP and international regulatory requirements.
• Experience with qualification and validation activities (equipment and computerized systems).
• Fluent in French and English (written and spoken).

Responsabilidades

• Provide QA oversight for equipment and utilities throughout their lifecycle (including commissioning, qualification, calibration and maintenance).
• Review and approve qualification documentation, including protocols and reports.
• Define and support risk-based qualification and validation strategies.
• Ensure equipment remains qualified through maintenance, calibration, change control and periodic reviews.

Conocimientos

Fluent French

Fluent English

Communication skills

Decision making

Educación

Science degree

Descripción del empleo

Incyte Corporation is seeking a QA Oversight professional to support QA for engineering and CSV activities at a large-scale biopharmaceutical manufacturing site in Yverdon-les-Bains, Switzerland.

The role focuses on ensuring qualification, validation and data integrity across equipment lifecycle, reviews of documentation, and collaboration with Engineering, Manufacturing and Validation to drive quality and compliance.