CSV Engineer

Prepare commissioning and validation documents for new systems, and supervise conversion, expansion, and new construction projects. This includes CSV activities for critical systems in new construction projects and SLC support for all systems post debut. Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict adherence to protocols. Coordinate CSV executions with internal groups, as well as external service providers and suppliers, to strictly ensure seamless integration. Present CSV documents during audits and inspections, showcasing our world-class standards. Schedule and report CSV activities, maintaining a flawless record of progress and outcomes. Align CSV strategy with QA CSV for all Biologics scope, showcasing our dedication to high standards. Contribute to the review and continuous amelioration of all CSV documents, ensuring ongoing optimization and success.

At Lonza, our people are our greatest strength. Spread across 30+ sites and five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity shape what we achieve and how we achieve it. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

• Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field or equivalent experience, showcasing your solid educational foundation.

• Significant experience in a regulated environment with regard to Computerized System Validation (CSV), demonstrating your proven expertise.

• Good knowledge of Microsoft Office and Delta-V, essential for your successful implementation of tasks.

• Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise, and SAP is an advantage, improving your ability to compete in our ambitious environment.

• Proficient in English, with German language skills being advantageous, enabling you to collaborate effectively in our diverse team.