CSV Engineer 80-100% (m/f/d)

Lonza seeks a CSV Engineer (80-100%) in Visp, Switzerland. The role focuses on validating computerized systems for process engineering equipment and facilities, including MES, while managing project-related validation activities throughout the system lifecycle.

This position ensures the validation and execution of computerized systems across process engineering equipment and facilities, including Manufacturing Execution Systems (MES). The role is responsible for managing validation activities that arise from ongoing projects and plant adaptations, ensuring these efforts align with the system lifecycle from planning through implementation.

Responsibilities

• Draft commissioning and validation documentation for new systems, and oversee conversion, expansion, and construction projects.
• Manage deviations, changes (GEP and GMP), and CAPAs while ensuring strict compliance with established protocols.
• Coordinate Computerized System Validation (CSV) activities with internal teams, external service providers, and suppliers to guarantee smooth integration.
• Present CSV documentation during audits and inspections, demonstrating adherence to high industry standards.
• Track and report on CSV activities, maintaining detailed records of progress and outcomes.
• Align CSV strategies with Quality Assurance CSV teams for all Biologics scope, maintaining high standards.
• Participate in reviewing and improving CSV documents to ensure continuous optimization and operational success.

Requirements

• Bachelor's, Master's, or Diploma from a technical school (HF), university of applied sciences (FH), or university in a technical field, or equivalent professional experience.
• Substantial background in regulated environments, specifically focusing on Computerized System Validation (CSV).
• Solid proficiency in Microsoft Office and Delta-V.
• Fluent English language skills.

Nice to have

• Familiarity with KNEAT, COMOS (a plant engineering software solution), DMS, TrackWise, and SAP.
• Ability to communicate in German.

What the company offers

• A highly valued CSV Engineer position based in Switzerland.
• A collaborative and innovative workplace designed to support creative ideas and world-class contributions.
• The opportunity to join a dedicated team focused on flawless execution and proven excellence in life sciences.
• The fulfillment of contributing to improvements in global health and quality of life.

About the company

Lonza operates as a global leader in life sciences, with a presence across three continents. The company prioritizes ethical success and is committed to respecting and protecting both its employees and the environment. Lonza empowers individuals to take ownership of their professional journeys.

• Employees are encouraged to take ownership of their career paths.
• The organization prioritizes the respect and protection of its workforce and the environment.
• Ethical success is a core company value.