Equipment Qualification & CSV Specialist

• Take part in the integration of strategic automated equipment. • Lead qualification activities and test execution. About Our Client ## 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. Job Description ## • 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 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 validation activities for embedded computerized systems. • Ensure compliance with Data Integrity principles and 21 CFR Part 11 requirements. • Collaborate closely with quality, engineering, automation teams, and suppliers. The Successful Applicant ## • 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. • Proficiency in writing and executing IQ/OQ/PQ protocols. • Practical 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 managing, investigating, and resolving deviations. • Ability to work independently and proactively. • Excellent writing skills in French and English. • Analytical mindset, rigor, and results orientation. What's on Offer ## • 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. Quote job ref JN-082026-7083817 Job Function Engineering & Manufacturing Specialisation Quality Industry Healthcare / Pharmaceutical Where Lausanne Region Contract Type Interim Job Reference JN-082026-7083817