CSV Specialist for Biologics Validation
Vor 3 Tagen
Role Overview
We are seeking a highly skilled CSV Specialist for Biologics Validation to join our team at Lonza. As a CSV Specialist, you will play a critical role in ensuring the validity and reliability of our computerized systems.
Key Responsibilities
- Develop and execute validation plans for computerized systems on process engineering equipment and facilities, including MES.
- Supervise the commissioning and validation of new systems, including CSV activities on new construction projects for critical systems and SLC support for all systems after going live.
- Coordinate with internal groups, external service providers, and suppliers to ensure seamless execution of CSV activities.
- Present CSV documents during audits and inspections.
- Schedule and report CSV activities.
- Align the CSV strategy with the QA CSV for the Biologics scope.
Requirements
- Bachelor's or Master's degree in a technical field.
- Significant experience in a regulated environment with regard to Computerized System Validation.
- Good knowledge of Microsoft Office and Delta-V.
- Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP is an advantage.
- Fluent in English, German language skills are advantageous.
About Lonza
At Lonza, we are committed to improving lives through science. We strive to create a work environment that is inclusive, respectful, and supportive of our employees' personal and professional growth.
We are proud to be a global leader in life sciences, operating across three continents. Our people are our greatest asset, and we empower them to make a meaningful difference in the world.
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