P>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. And that’s the kind of work we want to be part of.
As a Senior 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 contribute to the ongoing optimization of processes, facilities and internal procedures.
What you’ll get:
* An agile dynamic working culture
* An inclusive and ethical workplace
* Compensation programs that recognize high performance
* A variety of benefits dependent on role and location
* Relocation assistance for eligible candidates and their families
What you’ll do:
* Preparation of commissioning and validation documents for new systems, as well as the supervision of conversion, expansion and new construction projects. This is broken down into CSV activities on new construction projects for critical systems and SLC support for all systems after going live.
* Supervising the junior CSV Engineers including training and coaching.
What we’re looking for:
1. University degree in Computer Sciences/Life Sciences/Engineering or similar relevant experience.
2. Profound experience with CSV preferably in a CQV-CSV environment, Regulatory Compliance, Project and Lifecycle Management, Quality Assurance and Risk Management, Deviation/CAPA and Change Control.
3. Quality Assurance and Validation experience with FDA and EU regulations.
4. Fluency in English is required, and German language skills are an advantage.