CSV Engineer: Onsite Validation & Compliance Lead

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Inclusive workplace

Competitive salary

Lifestyle and family benefits

Local Visp benefits

Zusammenfassung

Lonza in Visp, Switzerland is seeking a CSV Engineer (m/f/d) to lead the generation and execution of validation activities for computerized systems on process engineering equipment and facilities.

The role requires working on site to support real-time collaboration and precision in manufacturing medicines. You will coordinate CSV activities, audits, and improvements across projects and plant life cycles, with opportunities to contribute to QA alignment for biologics.

Qualifikationen

• Significant experience in a regulated environment with regard to Computerized System Validation (CSV).
• Solid educational foundation in a technical field (Bachelor/Master/Diploma).
• Knowledge of industry software tools such as KNEAT, COMOS, DMS, TrackWise, SAP is advantageous.

Aufgaben

• Prepare commissioning and validation documents for new systems and supervise conversions, expansions, and new constructions including CSV activities for critical systems.
• Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict protocol adherence.
• Coordinate CSV executions with internal groups and external service providers to ensure seamless integration.
• Present CSV documents during audits and inspections to demonstrate high standards.
• Schedule and report CSV activities, maintaining a clear record of progress.
• Align CSV strategy with QA CSV for Biologics scope and contribute to ongoing optimization of CSV documents.
• Contribute to review and continual improvement of all CSV documents.

Kenntnisse

CSV validation experience

English proficiency

Ausbildung

Bachelor/Master/Diploma in technical field

Tools

KNEAT

COMOS

DMS

TrackWise

SAP

Jobbeschreibung

Lonza in Visp, Switzerland is seeking a CSV Engineer (m/f/d) to lead the generation and execution of validation activities for computerized systems on process engineering equipment and facilities.

The role requires working on site to support real-time collaboration and precision in manufacturing medicines. You will coordinate CSV activities, audits, and improvements across projects and plant life cycles, with opportunities to contribute to QA alignment for biologics.