Senior CSV Engineer

vor 2 Monaten

Visp, Schweiz Lonza Vollzeit

About Lonza

Lonza is a global leader in life sciences, operating across three continents. Our success is built on the expertise of talented individuals working together to develop innovative solutions that improve lives worldwide.

Job Summary

We are seeking a Senior CSV Engineer to join our team. As a key member of our Biologics department, you will be responsible for the generation and execution of validation activities for 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 of CSV processes.
  • Scheduling and Reporting: Schedule and report CSV activities, providing visibility into project progress and status.
  • CSV 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 Working at Lonza

We value our people and our environment, and we strive to achieve business results that are both successful and sustainable. If you're passionate about making a meaningful difference in the world, we invite you to explore this opportunity and join our team at Lonza.

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