Equipment Qualification & CSV Specialist

• 14 août 2026 • 100% • Temporary • Lausanne Our client is looking for an expert in Equipment Qualification and Computerized System Validation to support the integration of a new automated visual inspection line in a regulated environment. You will be responsible for the writing and execution of qualification activities as well as the management of deviations until their resolution, in compliance with quality and regulatory requirements. Equipment Qualification & CSV Specialist Our client is a recognized international player in the medtech sector, committed to innovation and operational excellence. Its stimulating environment offers the opportunity to participate in high value-added industrial projects in a demanding quality context. Missions • Participate in qualification activities related to the integration of an automated visual inspection line. • Review and approve SAT protocols. • Review and approve SAT reports. • Write IQ, OQ, and PQ qualification protocols. • Execute qualification tests in accordance with approved protocols. • Write qualification reports and ensure documentary traceability. • Identify, document, and investigate deviations detected during the qualification phases. • Coordinate corrective actions and follow up on the resolution of deviations. • Guarantee the compliance of activities with GMP requirements and applicable quality standards. • Participate in the validation activities of embedded computerized systems. • Ensure compliance with Data Integrity principles and 21 CFR Part 11 requirements. • Collaborate closely with quality, engineering, automation, and supplier teams. Candidate Profile • Higher education in engineering, life sciences, or a similar discipline. • 5 to 10 years of experience in equipment qualification and validation in a pharmaceutical or medical device environment. • Solid experience with complex automated lines and integrated industrial equipment. • Mastery of writing and executing IQ/OQ/PQ protocols. • Concrete experience in executing qualification tests in the field. • Good knowledge of embedded computerized systems and their validation. • Good knowledge of 21 CFR Part 11 regulations. • Experience in the management, investigation, and resolution of deviations. • Ability to work independently and proactively. • Excellent writing skills in French and English. • Analytical mind, rigor, and results orientation. Conditions and Benefits • A temporary mission to provide expertise. • Participation in a strategic automation project in an international and innovative environment. • High visibility, autonomy, and collaboration with quality, validation, and engineering experts.