CSV Engineer

Job Title: CSV Engineer (Computer Systems Validation)

Location: Ireland

Reports To: Project Manager/ CSV

Our client is a leading medical device company dedicated to improving patient care through innovative technology and high-quality products.

The CSV Engineer will play a key role in ensuring that all computer systems used in the development, manufacturing, and quality control of medical devices are validated in accordance with applicable regulatory standards.

Competencies:

• Validation of Computer Systems: Lead and support the validation activities for computer systems used in the development, manufacturing, and quality control of medical devices. This includes both hardware and software systems, ensuring they meet regulatory and quality requirements.
• Develop Validation Plans and Protocols: Prepare and execute CSV documentation such as Validation Plans, Protocols (IQ, OQ, PQ), Traceability Matrices, and Risk Assessments. Ensure all deliverables are in compliance with industry regulations and company policies.

Qualifications:

• Minimum of 5 years of experience in computer systems validation within the medical device or pharmaceutical industry.
• Solid understanding of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, GxP, and other relevant regulations.
• Experience with validation of systems in regulated environments (e.g., ERP, LIMS, SCADA, and laboratory equipment).