CSV Engineer
- Computer System Validation (CSV): Execute validation protocols and perform comprehensive testing on computer systems, ensuring compliance with relevant regulations (e.g., GxP, 21 CFR Part 11).
- Automated Systems and HMI: Conduct qualification and testing on automated systems that integrate with a Human-Machine Interface.
- Protocol Execution: Write and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Documentation: Prepare detailed documentation and reports of validation activities, test results, and compliance status.
- Collaboration: Work effectively within a cross-functional team, liaising with IT, quality assurance, and project management.
- Problem-Solving: Identify and troubleshoot issues discovered during the testing process and work with the team to resolve them.
- CSV Experience: Proven industry experience (3 years) in Computer System Validation within a regulated environment, preferably in the pharmaceutical, biotech, or medical device industry.
- HMI Expertise: Experience with validating automated systems that include a Human-Machine Interface.
- Bilingual Communication: Fluent in French (verbal and written) and capable of reading English technical documentation.
- Regulatory Knowledge: Familiarity with validation protocols, risk assessments, and regulatory compliance guidelines like GxP, GAMP 5, and 21 CFR Part 11.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and ability to produce high-quality documentation.
- Strong interpersonal and communication skills for effective team collaboration.
- Proactive and adaptable to an urgent project timeline.
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