CSV expert

Company Description

Eurofins Li-Med is focused on assisting in regulatory activities and quality assurance relating to the medical device industry. Our experts use their knowledge of non-clinical data to ensure compliance with regulation and approval for marketing and clinical trials.

Role Description

This is a full-time on-site role for a CSV Expert located in Petah Tikva. The CSV Expert will be responsible for developing, implementing, and maintaining the computer systems validation processes and associated documentation. They will also collaborate with cross-functional teams to identify business opportunities and provide customized solutions. The successful candidate will ensure complete and compliant documentation and will be responsible for the design and implementation of validation protocols, requirements, standards, documentation and testing within a regulated environment.

Qualifications

• Bachelor's degree in Computer Science, Computer Engineering or equivalent experience.
• At least 3 years of experience in CSV within a medical device or regulated industry.
• Strong knowledge of FDA and EU Medical Device Regulatory Requirements governing CSV and data integrity - Advantage
• Excellent knowledge of GMP, GAMP guidelines and other relevant industry standards - Advantage
• Experience in validation of computerized systems and software applications including LIMS, Data Management Systems, ERP systems, laboratory analytical instrumentation, and process control systems - Must
• Superb documentation, analytical, and problem-solving skills. Must be detail-oriented and have the ability to multi-task with minimal supervision. Ability to communicate complex technical ideas to both technical and non-technical audiences.
• Fluent in English with excellent communication skills both verbal and written.
• Ability to travel abroad up to twice a month.