Biologics CSV Validation Expert

vor 1 Woche

Visp, Schweiz Lonza Vollzeit

**About Us**

Lonza is a global leader in life sciences with operations across three continents. Our company's success stems from talented individuals working together to devise innovative solutions that help businesses improve people's lives.

We offer our employees the autonomy to own their careers, and we encourage them to contribute their ideas, no matter how big or small, to genuinely make a positive impact on the world.

**Job Summary**

We are seeking a skilled Biologics CSV Validation Expert to join our team. As a key member of our team, you will be responsible for the generation and execution of computerized system validation activities on process engineering equipment and facilities, including MES.

You will be responsible for following the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as contributing to the ongoing optimization of processes, facilities, and internal procedures.

**Key Responsibilities:**

  • CSV Activities Planning and Execution: Prepare commissioning and validation documents for new systems, supervise conversion, expansion, and new construction projects, including CSV activities on new construction projects for critical systems and SLC support for all systems after going live.
  • Deviation and Change Management: Supervise deviations, changes (GEP and GMP), and CAPAs.
  • CSV Executions Coordination: Coordinate CSV executions with internal groups, external service providers, and suppliers.
  • Audit and Inspection Support: Responsible for presenting CSV documents during audits and inspections.
  • Scheduling and Reporting: Schedule and report CSV activities.
  • Alignment and Review: Follow the alignment of the CSV strategy with the QA CSV for all Biologics scope and contribute to the review and improvement of all CSV documents.

**Requirements:**

  • Education: Bachelor's / Master's / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field.
  • Experience: Significant experience in a regulated environment with regard to Computerized System Validation (CSV).
  • Skills: Good knowledge of Microsoft Office and Delta-V is required. Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP is an advantage.
  • Language Skills: Fluent in English; German language skills are advantageous.

**Estimated Salary Range:** $80,000 - $110,000 per year, depending on location and experience.

**About the Role:** Every day, Lonza's products and services have a positive impact on millions of people. We respect and protect our people and our environment, ensuring that any success achieved is done ethically.

At Lonza, we value creativity and innovation, offering our employees the satisfaction of improving lives worldwide. If you're passionate about solving complex problems and developing new ideas in life sciences, we encourage you to apply for this role.

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