Sr. CSV Specialist

at  Lonza

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 and small, genuinely improve the world. And that’s the kind of work we want to be part of.
CSV Specialist reviews and approves documentation and oversees computerized system validation deliverables. • He/she reviews and approves the computerized system validation documents and procedures associated with computerized system operation, cleaning ama maintenance., design and configuration specifications, Electronic Records and Electronic Signatures (ERES) and Data Integrity Risk Assessments (DIRA). Provides computerized system and application support and conducts administration of GxP computerized systems.

Main responsibilities are:

• Overseeing computerized system validation (CSV)
• Review and approve Electronic Records and Electronic Signatures (ERES);
• Review and approve Data Integrity Risk Assessments (DIRA).
• Overseeing spreadsheet and software template validation
• Overseeing computerized systems, spreadsheet and software template life cycle
• Review and approve computerized system life cycle documents (including but not limited to audit trail review, authorizations concept, storage location security, data retention, backup and archiving procedures)
• Review and approve data migration test scripts and reports
• Review and approve tests scripts and reports
• Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice.
• Evaluation of software compliance with CFR 21 Part 11 / Annex 11.
• Conducting periodic review of validated GxP computerized systems: Data Integrity, Audit Trail, Authorizations and Permissions, Backup etc.
• Performing validation impact assessments prior to implementation of changes of the computerized systems and as part of deviations associated with computerized systems

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference

• Overseeing computerized system validation (CSV)
• Review and approve Electronic Records and Electronic Signatures (ERES);
• Review and approve Data Integrity Risk Assessments (DIRA).
• Overseeing spreadsheet and software template validation
• Overseeing computerized systems, spreadsheet and software template life cycle
• Review and approve computerized system life cycle documents (including but not limited to audit trail review, authorizations concept, storage location security, data retention, backup and archiving procedures)
• Review and approve data migration test scripts and reports
• Review and approve tests scripts and reports
• Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice.
• Evaluation of software compliance with CFR 21 Part 11 / Annex 11.
• Conducting periodic review of validated GxP computerized systems: Data Integrity, Audit Trail, Authorizations and Permissions, Backup etc.
• Performing validation impact assessments prior to implementation of changes of the computerized systems and as part of deviations associated with computerized system