CSV Specialist for Biologics Validation

Vor 3 Tagen


Visp, Schweiz Lonza Vollzeit

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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