QA CSV Engineer (m/f/d)

Key Responsibilities· Contribute to CSV strategies, plans, and protocols in accordance with regulatory As a QA IT CSV Engineer, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfill with regulatory requirements and operate as intended.Your primary responsibilities will include:guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5)· Contribute to risk assessments and participate to test scripts for computer system validation activities· Supervise validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)· Document validation activities, findings, deviations and CAPA in compliance with regulatory requirements· Conduct reviews and ensure software development adheres to industry standards and best practices· Collaborate with cross-functional teams, including Quality Assurance, IT, and subject matter experts, to ensure successful validation efforts

Requirements:

Required Qualifications· Bachelor's degree in Computer Science, Engineering, or a related technical field· Minimum of 4-7 years of experience in computer system validation or quality assurance roles within regulated industries· Comprehensive kledge of CSV regulations, guidelines, and industry standards (e.g., FDA, EMA, GAMP)· Proficiency in validation methodologies, tools, and techniques (e.g., risk assessment, test script development, defect management)· Strong analytical, problem-solving, and documentation skills· Excellent communication and interpersonal abilities for collaborating with cross-functional teams· Familiarity with software development life cycles and quality assurance practices· SAP S/4 HANA (or different version) experience neededPreferred Qualifications· Experience with validation of various computer systems (e.g., ERP, LIMS, MES, SDLC tools)· Kledge of Agile and DevOps methodologies and their impact on validation activities· French and English