CSV Specialist
4 weken geleden
Lonza, a global leader in life sciences, is seeking a skilled CSV Specialist to join our team. As a CSV Specialist, you will play a crucial role in ensuring the quality and integrity of our computerized systems.
Key Responsibilities:- Develop and execute Computerized System Validation activities, including facilities, utilities, validation life cycle, execution, technical documentation, process, GAP analysis, risk assessment, and more.
- Generate and execute user requirements, design specifications, functional specifications, and traceability matrices.
- Produce validation plans, IQ/OQ/PQ protocols, test scripts, and SOPs to meet 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP requirements.
- Develop CSV gap assessments and remediation plans, applying risk management principles.
- Support regulatory and client audits as a CSV subject matter expert.
- Identify efficiencies in the CSV program approach and apply lessons learned.
- Perform assigned Quality Systems activities, including document management, change control, non-conformities, and CAPAs.
- Write and/or revise procedures applicable to CSV activities.
- 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, able to work autonomously.
- Business-level fluency in English; other languages are nice to have but not required.
Lonza is committed to improving lives around the world through innovative solutions in life sciences. As a CSV Specialist, you will be part of a dynamic and diverse team, with opportunities for growth and development. If you are passionate about quality and integrity, and have a strong background in CSV, we encourage you to apply.
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CSV Specialist
2 weken geleden
Geleen, Limburg, Nederland Lonza VoltijdJob Title: CSV SpecialistJob Summary: We are seeking a highly skilled CSV Specialist to join our team at Lonza. As a CSV Specialist, you will be responsible for leading Computerized System Validation activities and ensuring compliance with regulatory requirements.Key Responsibilities:Develop and execute validation plans, protocols, and test scripts to meet...
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CSV Specialist
3 weken geleden
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.This specialized role will focus on Computerized System Validation activities, making you a highly important Subject Matter Expert within our wider team. You'll have the...
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CSV Specialist
4 weken geleden
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....
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CSV Specialist
1 maand geleden
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....
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CSV Specialist
4 weken geleden
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....
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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 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
2 weken geleden
Geleen, Limburg, Nederland Lonza VoltijdJoin Lonza's Team as a CSV SpecialistAt 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...
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Computerized System Validation Expert
3 dagen geleden
Geleen, Limburg, Nederland Lonza VoltijdRole OverviewLonza, a global leader in life sciences, is seeking a highly skilled CSV Specialist to join our team. As a CSV Specialist, you will play a crucial role in ensuring the validation of computerized systems, which is essential for maintaining the highest standards of quality and compliance.Key ResponsibilitiesConduct Computerized System Validation...
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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
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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CSV Specialist
5 maanden geleden
Geleen, Nederland Lonza VoltijdCSV Specialist Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
