CSV Lead 80-100% (f/m/d)

The actual location of this job is in Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

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. 

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying as a CSV Lead – OT Services!

Key responsibilities: 

• Lead computer system validation (CSV) workstream during initial qualification of laboratory systems located in the DPS Quality Control laboratories 

• Act as Local System Administrator and Service Owner for global laboratory applications and services 

• Own records in the quality system (e.g. Deviations, CAPAs, Changes) 

• Lead local projects and initiatives. Represent the site on global projects as needed 

• As needed, present topics to internal/external auditors. Respond to audit observations 

Key requirements: 

• Computer Science or Life Sciences degree or equivalent experience 

• A positive attitude and ability to be flexible and prioritize in a fast-paced environment. Ability to analyze and develop complex systems and processes. Analytical approach to problem solving 

• Direct experience working in project teams and leading project workstreams

• Solid experience with CSV including system development, configuration and administration, writing specifications, creating risk assessments, and writing/executing test plans 

• Experience working within a Quality System and ownership of quality records in a GxP environment, preferably in labs or in operations in the pharmaceutical industry

• Must be proficient in English both written (e.g. SOPs, validation documents) and spoken. German, French, or Italian are a significant plus 

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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.