Plant and Mechanical Engineering

CSV Engineer

Pau,  FranceOn-siteFreelanceStart date 10/2025
Posted by
Phaidon EPM London
Contact person
Gabriel Torres Feijo
Project ID
2921454
Title 21 of the Code of Federal RegulationsAutomationBiotechnologyRegulatory ComplianceInformation SystemsProject PlanningFrenchProject ManagementPersonal Attributes QuestionnairesQuality ManagementRegulatory SciencesRisk AnalysisTechnical DocumentationTestingValidation ProtocolsMedical MaterialGXP

Description

We are seeking a proactive and skilled CSV Engineer to join our team in Pau for a 6-month on-site mission. The successful candidate will be responsible for executing Computer System Validation (CSV) testing on both computer systems and automated systems with Human-Machine Interface (HMI). A strong understanding of GxP and regulatory compliance is essential. This is an urgent request, and the candidate must be available for an early October start.

Key responsibilities
  • 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.
Required competencies
  • 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.
Personal attributes
  • 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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