As a CSV Engineer (m/f/d), you will be responsible for the generation and execution of the validation of computerized systems on process engineering equipment and facilities. You will follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle, and contribute to the ongoing optimization of processes, facilities, and internal procedures. This role is primarily based on site, supporting close, real-time collaboration and technical precision needed to manufacture medicines to the highest quality and safety standards.
Tasks
- Prepare commissioning and validation documents for new systems, and supervise conversion, expansion, and new construction projects.
- Conduct CSV activities for critical systems in new construction projects and provide 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 ensure seamless integration.
- Present CSV documents during audits and inspections.
- Schedule and report CSV activities, maintaining a record of progress and outcomes.
- Align CSV strategy with QA CSV for all Biologics scope.
- Contribute to the review and continuous improvement of all CSV documents.
Requirements
- Bachelor, Master, Diploma from a technical school (HF), university of applied sciences (FH), university in a technical field, or equivalent experience.
- Significant experience in a regulated environment with regard to Computerized System Validation (CSV).
- Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise, and SAP is an advantage.
- Proficient in English; German language skills are advantageous.
Benefits
- Relocation assistance is available for eligible candidates and their families, if needed.
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Competitive salary with numerous lifestyle, family, and leisure benefits.
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