Biologics Validation Specialist
vor 2 Wochen
Job Summary
We are seeking a skilled Biologics Validation Specialist to join our team at Lonza.
Key Responsibilities
- Develop and execute validation plans for computerized systems on process engineering equipment and facilities, including MES.
- Collaborate with internal groups, external service providers, and suppliers to ensure successful CSV executions.
- Present CSV documents during audits and inspections.
- Schedule and report CSV activities.
- Align CSV strategy with QA CSV for all Biologics scope.
- Review and improve CSV documents.
Requirements
- Bachelor's or Master's degree in a technical field.
- Significant experience in a regulated environment with regard to CSV.
- Proficiency in Microsoft Office and Delta-V.
- Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP is an advantage.
- Fluency in English, German language skills are advantageous.
About Lonza
At Lonza, we strive to make a meaningful difference in people's lives through our products and services.
We prioritize ethical business practices and respect for our people and the environment.
Lonza is a global leader in life sciences operating across three continents.
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