Senior QA Engineer, Equipment Qualification & CSV

Incyte; Yverdon-les-Bains; Sur place; CHF 120 000 - 180 000; Plein temps

Résumé du poste

Incyte seeks a Quality Assurance professional to oversee the engineering and CSV lifecycle at its Yverdon-les-Bains facility in Switzerland. You will ensure cGMP compliance, review qualification documentation, and drive validation strategies across equipment, utilities and computerized systems.

Collaboration with Engineering, Manufacturing and Validation teams is essential to uphold data integrity and regulatory readiness.

Qualifications

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
• Firsthand experience of min 5 years in an Engineering / CSV position with confirmed experience in a Quality position
• Thorough knowledge in cGMP and international regulatory requirements
• Thorough knowledge in qualification and validation activities (equipment and computerized system)
• Fluent in French and English written and spoken
• Ability to make pragmatic and compliant decisions
• Strong result orientation and committed team member
• Good written and verbal communication skills.

Responsabilités

• Provide QA oversight for equipment and utilities throughout their lifecycle (including Commissioning & Qualification, Calibration and Maintenance)
• Review and approve qualification documentation, including qualification protocols and reports
• Define and support risk-based qualification and validation strategies
• Ensure equipment remains in a qualified state through maintenance, calibration, change control and periodic review
• Act as SME for complex qualifications, validation and compliance topics
• Provide QA oversight for computerized functionalities associated with GxP equipment
• Review and approve CSV documentation related to equipment software and automated systems
• Ensure data integrity requirements are implemented and maintained during equipment lifecycle
• Assess quality and compliance impacts related to equipment implementation, modifications and upgrades
• Review and approve deviations, investigations, CAPAs, change controls and risk assessments related to equipment
• Support introduction of new laboratory and manufacturing equipment from a QA perspective
• Support complex quality initiatives related to equipment qualification, validation and compliance
• Partner with Engineering, Manufacturing, Maintenance and Validation stakeholders to identify and mitigate quality risks
• Review and approve SOPs, work instructions and quality documentation related to equipment qualification, validation, maintenance and lifecycle management
• Review and approve periodic reviews, audit trail assessments and data integrity controls for computerized equipment
• Escalate quality risks and support remediation actions
• Participate in internal audits and regulatory inspections and support inspection readiness
• Drive continuous improvement initiatives related to equipment lifecycle management and validation processes
• Promote quality culture and understanding of cGMP across functions
• Promote risk-based, compliant approaches per GMP standards

Connaissances

cGMP knowledge

Quality oversight

Regulatory compliance

DocumentationReview

Bilingual English/French

Formation

Natural or applied sciences degree

Description du poste

Incyte seeks a Quality Assurance professional to oversee the engineering and CSV lifecycle at its Yverdon-les-Bains facility in Switzerland. You will ensure cGMP compliance, review qualification documentation, and drive validation strategies across equipment, utilities and computerized systems.

Collaboration with Engineering, Manufacturing and Validation teams is essential to uphold data integrity and regulatory readiness.