Lead QA Engineer — Equipment Qualification & CSV

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Fluent French

Fluent English

Communication skills

Decision making

Ausbildung

Science degree

Jobbeschreibung

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.