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Responsibilities
Key ResponsibilitiesPrepare commissioning and validation documents for new systems, and supervise conversion, expansion, and new construction projects. This includes CSV activities for critical systems in new construction projects and SLC support for all systems post debut.Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict adherence to protocols.Coordinate CSV executions with internal groups, as well as external service providers and suppliers, to strictly ensure seamless integration.Present CSV documents during audits and inspections, showcasing our world-class standards.Schedule and report CSV activities, maintaining a flawless record of progress and outcomes.Align CSV strategy with QA CSV for all Biologics scope, showcasing our dedication to high standards.Contribute to the review and continuous amelioration of all CSV documents, ensuring ongoing optimization and success.As a CSV Engineer (m/f/d) you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities, including MES. You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as make a contribution to the ongoing optimization of processes, facilities and internal procedures.Key requirements:Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field or equivalent experience, showcasing your solid educational foundation.Significant experience in a regulated environment with regard to Computerized System Validation (CSV), demonstrating your proven expertise.Good knowledge of Microsoft Office and Delta-V, essential for your successful implementation of tasks.Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise, and SAP is an advantage, improving your ability to compete in our ambitious environment.Proficient h German language skills being advantageous, enabling you to collaborate effectively in our diverse team.At Lonza, we offer an outstanding opportunity for a CSV Engineer in Switzerland. Our collaborative and innovative work environment is crafted to let your ideas thrive and make a world-class impact.Every day, Lonza’s products and services have a positive impact on millions of people.
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