Computerized System Validation Expert

vor 4 Wochen

Visp, Schweiz Lonza Vollzeit

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 process engineering team, 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:

  • CSV Activities Planning and Implementation: Prepare commissioning and validation documents for new systems, supervise conversion, expansion, and new construction projects, and ensure CSV activities are executed according to the system life cycle.
  • Deviation and Change Management: Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring compliance with regulatory requirements.
  • CSV Execution 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.
  • 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: Good knowledge of Microsoft Office and Delta-V, with knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP being an advantage.
  • Language Skills: Fluency in English, with German language skills being advantageous.

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 talented individuals who share our passion for science and innovation. As a CSV Engineer - Biologics Validation Specialist, you will be part of a dynamic team that is dedicated to delivering high-quality products and services that make a meaningful difference in people's lives.

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