Senior CSV Systems Engineer
Vor 3 Tagen
At Lonza, we rely on talented individuals to drive our scientific solutions forward. We're currently seeking a highly skilled Senior CSV Systems Engineer to join our team.
About the Role:
As a Senior CSV Systems Engineer, you will be responsible for generating and executing the validation of computerized systems on process engineering equipment and facilities, including MES. You will follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants.
Key Responsibilities:
- Prepare commissioning and validation documents for new systems, as well as supervise conversion, expansion, and new construction projects.
- Supervise deviations, changes (GEP and GMP), and CAPAs.
- Coordinate CSV executions with internal groups, as well as external service providers and suppliers.
- Responsible for the presentation of CSV documents during audits and inspections.
- Scheduling and reporting of CSV activities.
- Follow the alignment of the CSV strategy with the QA CSV for all Biologics scope.
- Contribution in the review and amelioration of all CSV documents.
Key Requirements:
- Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field.
- Significant experience in a regulated environment with regard to Computerized System Validation (CSV).
- Good knowledge of Microsoft Office and Delta-V is required.
- Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise, and SAP is an advantage.
- Fluent in English, German language skills are advantageous.
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