Qualification Engineer

vor 15 Stunden


Basel, Schweiz agap2 Switzerland Vollzeit

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from agap2 Switzerland Specialist in hiring engineers, pharmacists and business managers for Life Science in Switzerland agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills. You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio. Your Mission Become a key player in a brand-new greenfield project where you will help build, qualify, and launch state-of-the-art production and packaging lines from the ground up. This is your chance to shape an entire facility’s future in a high-growth biotech/pharma/medtech environment. You will take part in every critical stage of bringing new systems to life: Define technical expectations by developing high-impact URS and performing comprehensive risk analyses (FMEA, FRA) Lead the creation and review of the Validation Master Plan (VMP) for newly installed equipment, utilities, and production areas Design, write, and optimize qualification and commissioning protocols (FAT/SAT/IQ/OQ/PQ) for new production lines, new packaging lines, and new utilities under strict GMP/MDR requirements Actively participate in FAT/SAT at supplier sites and on-site to ensure flawless equipment delivery and readiness Execute and document IQ/OQ/PQ activities to qualify all new systems and guarantee GMP-compliant startup Collaborate closely with engineering, suppliers, and operations to bring an entire greenfield site to operational excellence Your Profile – Ready to Build What Doesn’t Exist Yet You are motivated by large-scale challenges and #J-18808-Ljbffr


  • QA qualification engineer

    vor 15 Stunden


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    QA Qualification Engineer Join to apply for the QA qualification engineer role at agap2 Switzerland. agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. As...


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  • Basel, Schweiz agap2 Switzerland Vollzeit

    Overview Join to apply for the QA qualification engineer role at agap2 Switzerland. agap2 is a European engineering and operational consulting group founded in 2005, specialized in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. As a consultant, you will support clients in the...

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