CSV Engineer Biologics (80-100%)
lonza · Visp
Description du poste
About the role
As a CSV Engineer you will lead the generation and execution of validation activities for computerized systems used in process engineering equipment and facilities. The role is site‑based in Visp, supporting real‑time collaboration to ensure medicines are manufactured to the highest quality and safety standards.
Key responsibilities
- Prepare commissioning and validation documentation for new systems and supervise conversion, expansion, and new construction projects.
- Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring strict protocol adherence.
- Coordinate CSV execution with internal groups, external service providers, and suppliers for seamless integration.
- Present CSV documents during audits and inspections and align CSV strategy with QA for the Biologics scope.
Required profile
- Bachelor/Master/Diploma in a technical field or equivalent experience.
- Significant experience in a regulated environment with Computerized System Validation.
- Proficiency in English; German language skills are advantageous.
Required skills
- KNEAT
- COMOS (plant engineering software)
- DMS
- TrackWise
- SAP
What we offer
- Agile career and dynamic working culture.
- Inclusive and ethical workplace.
- Competitive salary with lifestyle, family, and leisure benefits.
- Relocation assistance for eligible candidates and families.
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lonza
Visp
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