Senior CSV Biologics Lead

vor 3 Wochen

Visp, Schweiz Lonza Vollzeit

At Lonza, we're driven by a passion for life sciences and a commitment to excellence. As a global leader in this field, we recognize that our greatest strength lies in the talented people who work with us. In the Biologics organization, we're seeking a Senior CSV Biologics Lead to lead a team of CSV engineers on several projects. This role requires a deep understanding of bioprocesses, GMP, and biopharma productions computerized systems.

Key Responsibilities:

  • Team Leadership: Manage a team of CSV experts with full responsibility for all aspects of human resource management, including qualification, development, coaching, hiring, pay decisions, and discipline issues.
  • CSV Expertise: Set up and manage a local group of CSV experts on CSV activities linked to biologics facilities and provide support to future operations users during initial and periodic validation.
  • Capital Investment Projects: Work with your team in capital investment projects and strengthen the respective operations teams with expert knowledge on CSV.
  • CSV Activities Planning: Participate in planning CSV activities to ensure correct operations and resources are included for each project step.
  • CSV Standardization: Secure operations input to CSV and define and standardize the CSV approach.
  • Ssupplier Management: Create and manage a trust with suppliers that will support CSV operations.
  • LONZA Culture: Support the implementation of LONZA culture via openness for change and new ideas, cooperative teamwork, and continuous improvement. 

Requirements:

  • Bachelor / Master / Diploma from a technical school or university in a technical field.
  • Extensive experience in the area of Computerized System Validation (CSV) in a biotech-related environment.
  • Depth understanding of bioprocesses, GMP, and biopharma productions computerized systems.
  • Strong experience in DeltaV, KNEAT, and project management.
  • Strong leadership skills and ability to communicate internally and externally at higher levels.
  • Fluent in English; German language skills are advantageous. 

At Lonza, we believe that our people are our greatest asset. We offer a dynamic and challenging work environment that fosters creativity, innovation, and growth. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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