Computerized System Validation Specialist
2 weken geleden
At Lonza, we're committed to improving lives around the world through innovative life sciences solutions. We're seeking a talented CSV Specialist to join our team in Geleen, Netherlands.
About the RoleThe CSV Specialist will play a crucial role in our Qualification and Validation Team, focusing on Computerized System Validation activities. As a Subject Matter Expert, you'll be responsible for ensuring the validation of our computerized systems meets the highest standards of quality and regulatory compliance.
Key Responsibilities- Develop and execute validation plans, protocols, and test scripts for computerized systems, ensuring compliance with 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5.
- Conduct gap assessments and remediation plans, applying risk management principles to ensure the validation of our systems.
- Support regulatory and client audits as a CSV subject matter expert, providing guidance and expertise to ensure compliance.
- Identify and implement efficiencies in the CSV program approach, applying lessons learned and staying informed of industry regulatory changes.
- Perform quality systems activities, including document management, change control, non-conformities, and CAPAs.
- Bachelor's degree or equivalent in a relevant subject area.
- Demonstrable experience within CSV in a GMP environment, with an excellent understanding of good documentation practices, data integrity, and ALCOA++.
- Knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5.
- Strong planning skills and self-motivation, with the ability to work autonomously.
- Business-level fluency in English; other languages are a plus.
At Lonza, we're dedicated to making a meaningful difference in people's lives. We believe in the importance of ethics, integrity, and sustainability in everything we do. Our team is passionate about solving complex problems and developing innovative solutions in life sciences. If you're looking for a challenging and rewarding career, join us at Lonza and be part of our mission to improve lives around the world.
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Computerized System Validation Specialist
2 weken geleden
Geleen, Limburg, Nederland Lonza VoltijdAt Lonza, we are seeking a highly skilled Computerized System Validation Specialist to join our team. This specialized role will focus on Computerized System Validation activities and is a highly important Subject Matter Expert within the wider team.The CSV Validation Expert will be involved in all Computerized System Validation activities, including but not...
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Computerized System Validation Specialist
1 dag geleden
Geleen, Limburg, Nederland Lonza VoltijdJob DescriptionWe are seeking a highly skilled CSV Specialist to join our team at Lonza in Geleen.This specialized role will focus on Computerized System Validation activities and is a highly important Subject Matter Expert within the wider team.The CSV Specialist will be involved in all Computerized System Validation activities including facilities,...
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Computerized System Validation Expert
7 dagen geleden
Geleen, Limburg, Nederland Lonza VoltijdJob SummaryWe are seeking a highly skilled Computerized System Validation Expert to join our team at Lonza. As a CSV Specialist, you will play a crucial role in ensuring the validation of our computerized systems, ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and execute validation plans, protocols, and test scripts for...
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Computerized System Validation Expert
1 week geleden
Geleen, Limburg, Nederland Lonza VoltijdAt Lonza, we are seeking a highly skilled Computerized System Validation Expert to join our team. This specialized role will focus on Computerized System Validation activities and is a highly important Subject Matter Expert within the wider team.The CSV Specialist - Life Sciences will be involved in all Computerized System Validation activities, including...
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Computerized System Validation Expert
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Geleen, Limburg, Nederland Lonza VoltijdJoin Our Team as a CSV SpecialistLonza is a global leader in life sciences, operating across three continents. We're seeking a talented CSV Specialist to join our team in Geleen, Netherlands.About the RoleThis specialized role will focus on Computerized System Validation activities, making you a highly important Subject Matter Expert within our wider team....
