CSV Engineer
vor 2 Monaten
Job Summary
We are seeking a highly skilled CSV Engineer - Biologics Validation Specialist to join our team at Lonza. As a key member of our life sciences organization, you will be responsible for the generation and execution of the validation of computerized systems on process engineering equipment and facilities, including MES.
Key Responsibilities:
- Validation Planning and Execution: Develop and execute validation plans for new systems, including commissioning and validation documents, and supervise conversion, expansion, and new construction projects.
- Deviation and Change Management: Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring compliance with regulatory requirements.
- CSV Coordination: Coordinate CSV executions with internal groups, external service providers, and suppliers, ensuring seamless project delivery.
- Audit and Inspection Support: Present CSV documents during audits and inspections, demonstrating expertise and knowledge.
- Scheduling and Reporting: Schedule and report CSV activities, providing visibility into project progress.
- Strategy Alignment: Align the CSV strategy with the QA CSV for all Biologics scope, ensuring consistency and compliance.
- Document Review and Improvement: Contribute to the review and improvement of all CSV documents, ensuring accuracy and effectiveness.
Requirements:
- Education: Bachelor's or Master's degree in a technical field from a recognized institution.
- Experience: Significant experience in a regulated environment with regard to Computerized System Validation (CSV).
- Technical Skills: Proficiency in Microsoft Office and Delta-V, with knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP an advantage.
- Language Skills: Fluency in English, with German language skills an advantage.
About Lonza:
Lonza is a global leader in life sciences, operating across three continents. We are committed to improving lives through innovative solutions, and we value our people and the environment. Our work is guided by a strong sense of responsibility and a passion for making a meaningful difference.
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