Biologics CSV Engineer
vor 2 Wochen
At Lonza, we're committed to improving lives through innovative life sciences solutions. As a CSV Engineer Biologics, you'll play a crucial role in ensuring the validation of computerized systems on process engineering equipment and facilities, including MES. Your expertise will help us maintain the highest standards of quality and compliance.
Key Responsibilities:
- Prepare commissioning and validation documents for new systems, including CSV activities on new construction projects for critical systems and SLC support for all systems after going live.
- Supervise deviations, changes (GEP and GMP), and CAPAs, ensuring seamless execution and compliance.
- Coordinate CSV executions with internal groups, external service providers, and suppliers, fostering collaboration and efficiency.
- Present CSV documents during audits and inspections, showcasing your expertise and attention to detail.
- Schedule and report CSV activities, aligning with QA CSV for all Biologics scope.
Requirements:
- Bachelor's or Master's degree in a technical field from a recognized institution.
- Significant experience in a regulated environment with regard to Computerized System Validation (CSV).
- Proficiency in Microsoft Office and Delta-V, with knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP an advantage.
- Fluent English language skills, with German language skills advantageous.
About Lonza
At Lonza, we're dedicated to making a meaningful difference in people's lives. Our products and services have a positive impact on millions of people worldwide. We're committed to respecting and protecting our people and the environment, and we strive to achieve our business results with integrity and ethics.
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