CSV Engineer Netherlands

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.

• 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.

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