CSV Engineer Switzerland
Direct Ltd
18 days ago
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
EnglishJob location
Tech stack
Data Integrity
Software Systems
Information Technology
GXP
Job description
- Work with relevant Change Owners for all GxP IT systems to identify and mitigate risks, ensuring all changes are tracked to completion.
- Prepare and execute core CSV deliverables, including validation protocols, summary reports, and periodic system reviews.
- Provide technical assessment and system support for quality deviations and non-conformances.
- Recommend and manage Corrective and Preventive Actions (CAPAs) to enhance system compliance and performance.
- Author and maintain SOPs and work instructions governing the operation, maintenance, and compliance of software systems.
- Collaborate with IT and process owners to ensure the compliance of software systems throughout the entire system lifecycle.
- Ensure adherence to CSV procedures during system implementations and provide support for new software projects, including updates to the validation master plan.
- Serve as the subject matter expert for CSV during internal and external regulatory audits.
- Coordinate with the Validation department to align CSV processes with broader site validation policies and standards.
- Research and propose the implementation of new technologies to improve business and compliance processes.
Requirements
- Proven professional experience within a Pharmaceutical, Life Science, or similarly regulated GxP environment.
- Extensive background in Computer Systems Validation (CSV) or a higher education qualification in Computer Science or a related technical discipline.
- Strong understanding of IT Infrastructure and Networks.
- Practical knowledge of IT Qualification (IQ) activities and documentation.
- Familiarity with industry standards such as GAMP 5 and Data Integrity regulations.
