Job Description:
Lonza is a global leader in life sciences, operating across three continents. Our greatest scientific solution lies in talented people working together to devise ideas that help businesses improve lives.
We are seeking a Senior CSV Engineer Biologics to generate and execute the validation of computerized systems on process engineering equipment and facilities, including MES. You will be responsible for planning and implementing CSV activities resulting from projects and plant adaptations during the system lifecycle.
Key Responsibilities:
* Prepare commissioning and validation documents for new systems, supervising conversion, expansion, and new construction projects.
* Supervise deviations, changes, and CAPAs, coordinating CSV executions with internal groups and external service providers.
* Present CSV documents during audits and inspections, scheduling and reporting CSV activities.
* Foster alignment between the CSV strategy and QA CSV for all Biologics scope, contributing to the review and improvement of CSV documents.
Requirements:
* Bachelor's or Master's degree in a technical field from a recognized institution.
* Significant experience in regulated environments with regard to Computerized System Validation (CSV).
* Proficiency in Microsoft Office and Delta-V.
* Familiarity with KNEAT, COMOS, DMS, TrackWise, and SAP is an advantage.
* Fluency in English, with German language skills advantageous.
Lonza values innovation, creativity, and collaboration. We offer opportunities for professional growth and development in a dynamic, global environment.