CSV Engineer - Biologics (m/f/d)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

At Lonza, we offer an outstanding opportunity for a CSV Engineer in Switzerland. Our collaborative and innovative work environment is crafted to let your ideas thrive and make a world-class impact. Join us and be part of an ambitious team that aims for flawless execution and proven excellence in life sciences.

As a CSV Engineer Biologics (m/f/d) you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities, including MES. You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as make a contribution to the ongoing optimization of processes, facilities and internal procedures.

Key responsibilities:

• 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.

Key requirements:

• 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.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.