Lonza
Team Lead CSV Biologics(m/w/x)
Full-timeOn-siteSenior
Visp
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Defining and maintaining site strategy for computerized system validation and data integrity in pharma/biotech. Knowledge of GxP, Annex 11, 21 CFR Part 11, and GAMP 5 essential. Work in a global life sciences organization.
Requirements
- Degree in Computer Science, Engineering, Life Sciences or similar
- Experience in pharma/biotech QA, CSV and Data Integrity
- Knowledge of GxP, Annex 11, 21 CFR Part 11 and GAMP 5
- Understanding of system lifecycle and computerized systems
- Strategic mindset, decision-making and stakeholder alignment skills
- Experience in audits/inspections related to CSV & DI
- Excellent communication skills in English & German
Tasks
- Define and maintain the site CSV strategy
- Align strategies with global standards and regulatory requirements
- Act as the QA CSV authority in projects
- Ensure compliant system lifecycle management
- Evaluate digital technologies for CSV and Data Integrity controls
- Drive harmonization and global alignment of CSV processes
- Make strategic decisions on CSV risks and validation approaches
- Present local CSV strategies during audits and inspections
- Approve key CSV deliverables and inspection-ready documentation
- Provide SME support and cross-functional guidance
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- CSV
- Data Integrity
- GxP
- Annex 11
- 21 CFR Part 11
- GAMP 5
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Learning & Development
- Agile career opportunities
Startup Environment
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Defining and maintaining site strategy for computerized system validation and data integrity in pharma/biotech. Knowledge of GxP, Annex 11, 21 CFR Part 11, and GAMP 5 essential. Work in a global life sciences organization.
Requirements
- Degree in Computer Science, Engineering, Life Sciences or similar
- Experience in pharma/biotech QA, CSV and Data Integrity
- Knowledge of GxP, Annex 11, 21 CFR Part 11 and GAMP 5
- Understanding of system lifecycle and computerized systems
- Strategic mindset, decision-making and stakeholder alignment skills
- Experience in audits/inspections related to CSV & DI
- Excellent communication skills in English & German
Tasks
- Define and maintain the site CSV strategy
- Align strategies with global standards and regulatory requirements
- Act as the QA CSV authority in projects
- Ensure compliant system lifecycle management
- Evaluate digital technologies for CSV and Data Integrity controls
- Drive harmonization and global alignment of CSV processes
- Make strategic decisions on CSV risks and validation approaches
- Present local CSV strategies during audits and inspections
- Approve key CSV deliverables and inspection-ready documentation
- Provide SME support and cross-functional guidance
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- CSV
- Data Integrity
- GxP
- Annex 11
- 21 CFR Part 11
- GAMP 5
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Learning & Development
- Agile career opportunities
Startup Environment
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- Lonza
Team Lead CSV Biologics(m/w/x)
Full-timeOn-siteSeniorVisp - CH12 Lonza AG
CSV Engineer(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
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Full-timeOn-siteSeniorVisp - Lonza
Head of QA Mammalian(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Full-timeOn-siteSeniorVisp