CSV Engineer Netherlands

Resourcing Life Science; Netherlands; On-site; EUR 60,000 - 80,000; Full time

Job summary

A pharmaceutical consulting company based in the Netherlands is seeking a professional with expertise in managing GxP IT systems. The role involves ensuring compliance with regulatory standards, preparing essential validation documents, and serving as a subject matter expert for audits. Candidates should have extensive experience in Computer Systems Validation and a strong understanding of IT infrastructure. This position offers an opportunity to enhance system compliance and improve business processes through technological advancements.

Qualifications

• Proven experience in a Pharmaceutical, Life Science, or GxP environment.
• Extensive background in Computer Systems Validation.
• Strong understanding of IT Infrastructure.

Responsibilities

• Manage risks associated with GxP IT systems.
• Prepare core CSV deliverables and reports.
• Support quality deviations and non-conformances.
• Ensure compliance during system lifecycles and audits.

Skills

Computer Systems Validation (CSV)

IT Infrastructure knowledge

Data Integrity regulations

Education

Higher education in Computer Science or related technical discipline

Job description

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.