CSV Engineer

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View: 126

Update day: 26-03-2024

Location: Visp Valais VS

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Staffing Recruiting

Position: Entry level

Job type: Full-time

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CSV Engineer - 12 monthsheadcount AG is a Zurich-based consultancy serving clients in the pharmaceutical, biotechnology, medical technology, diagnostic, OTC and chemical market segments.Our client is a global manufacturer which facilitates cutting-edge pharmaceutical, biotech, and nutritional processes. They leverage scientific innovation to develop customized solutions at all stages, from drug discovery and manufacturing up to clinical trial stages for a wide range of products.Responsibilities_Act as a Subject Matter Expert (SME) in following CQV CSV standards_CSV person of contact of the assigned system till the handover to the operation organization_Create the test protocols and execute the tests. Participate in system impact assessment as CSV SME. Participate in the inspection as the CSV-representative_Define with EMR and Package Units vendor the most appropriate design for vertical integration for our client_Participate in the FAT & SAT._DeputizingRequirements_Experience in automation, vertical integration, data management under validated computer systems._5+ years in Commissioning, Qualification and Validation incl.CSV in pharmaceutical projects._Strong knowledge of ISPEGAMP5 and ASTM guidelines with proven experience on large and complex projects. Proven management experience in an EMA / FDA-regulated environment with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation._Fluent in English and German_Bachelor’s degree in engineering or applied science***Please only apply if you are eligible to work in Switzerland and the EU******Please forward your application should you meet the requirements above - applications which do not meet these requirements will not be considered***headcount AGXiao WuDreikönigstrasse 558002 Zürichxiao@headcount.chheadcount.ch
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Deadline: 10-05-2024

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