CSV Engineer: Onsite Validation for Biologics Systems

Lonza Group Ltd.; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Performance bonuses

Lifestyle benefits

Visp benefits list

Zusammenfassung

Lonza Group Ltd. is seeking a CSV Engineer (m/f/d) to generate and execute validation of computerized systems on process equipment and facilities at our Visp site in Switzerland. The role focuses on commissioning, validation, and project support across lifecycle stages.

You will coordinate CSV activities, supervise deviations and CAPAs, and present documents during audits. Proficiency in English is required and German is a plus; relocation assistance is available for eligible candidates.

Qualifikationen

• Solid educational foundation in a technical field.
• Significant experience in a regulated environment with CSV.
• Proficiency in English; German language skills advantageous.

Aufgaben

• Prepare commissioning and validation documents for new systems, and supervise conversion, expansion, and new construction projects.
• CSV activities for critical systems in new construction projects and post-debut life-cycle support.
• Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict adherence to protocols.
• Coordinate CSV executions with internal groups and external service providers to ensure seamless integration.
• Present CSV documents during audits and inspections, demonstrating high standards.
• Schedule and report CSV activities, maintaining a flawless progress record.
• Align CSV strategy with QA CSV for Biologics scope.
• Contribute to review and continuous improvement of all CSV documents.

Kenntnisse

CSV validation experience

English proficiency

GxP knowledge

Project coordination

Ausbildung

Bachelor/Master in technical field

Tools

KNEAT

COMOS

DMS

TrackWise

SAP

Jobbeschreibung

Lonza Group Ltd. is seeking a CSV Engineer (m/f/d) to generate and execute validation of computerized systems on process equipment and facilities at our Visp site in Switzerland. The role focuses on commissioning, validation, and project support across lifecycle stages.

You will coordinate CSV activities, supervise deviations and CAPAs, and present documents during audits. Proficiency in English is required and German is a plus; relocation assistance is available for eligible candidates.