CSV Engineer Switzerland

Resourcing Life Science; Schweiz; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading life sciences recruitment firm is seeking a qualified candidate for a role focusing on Computer Systems Validation (CSV) in Switzerland. You will be responsible for identifying risks, preparing validation deliverables, and managing compliance within GxP IT systems. Ideal applicants should have experience in regulated environments, a solid understanding of IT infrastructure, and strong technical writing skills. This position offers a chance to enhance system compliance and performance through collaboration and expertise.

Qualifikationen

• Extensive background in Computer Systems Validation (CSV) or a higher education qualification.
• Proven professional experience within a regulated GxP environment.
• Strong understanding of IT Infrastructure and Networks.

Aufgaben

• Work with Change Owners to identify and mitigate risks.
• Prepare and execute core CSV deliverables.
• Provide technical assessment and support for quality deviations.
• Manage Corrective and Preventive Actions (CAPAs).
• Author and maintain SOPs governing software systems.

Kenntnisse

Change management

Risk assessment

Technical writing

Problem-solving

Collaboration

Ausbildung

Degree in Computer Science or related discipline

Jobbeschreibung

Responsibilities

• 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.

Key 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.

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]