Biologics CSV Specialist
vor 4 Wochen
At Lonza, we're driven by a passion for life sciences and a commitment to excellence. As a Biologics CSV Specialist, you'll play a critical role in ensuring the integrity of our computerized systems, ensuring they meet the highest standards of quality and compliance.
Key Responsibilities:
- Develop and execute commissioning and validation plans for new systems, ensuring seamless integration and minimal disruption to operations.
- Supervise deviations, changes, and CAPAs, ensuring timely resolution and minimal impact on production.
- Collaborate with internal teams and external service providers to coordinate CSV activities, ensuring alignment with QA CSV strategy.
- Present CSV documents during audits and inspections, showcasing your expertise and attention to detail.
- Schedule and report CSV activities, providing visibility into project progress and status.
- Contribute to the review and improvement of CSV documents, ensuring they remain up-to-date and compliant.
Requirements:
- Bachelor's or Master's degree in a technical field, such as computer science or engineering.
- Significant experience in a regulated environment, with a strong understanding of Computerized System Validation (CSV) principles and practices.
- Proficiency in Microsoft Office and Delta-V, with knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP a plus.
- Fluency in English, with German language skills a valuable asset.
At Lonza, we're committed to making a meaningful difference in the lives of millions of people around the world. Join us in our mission to deliver innovative solutions that improve lives and advance the field of life sciences.
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