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Senior CQV Engineer

2 months ago

Fontana, United States Consultys Full time

This opportunity requires long-term relocation to the Copenhagen area in Denmark. Consultys provides work visa sponsorship for this position.

Ready to make your application Please do read through the description at least once before clicking on Apply.

Job Summary

Join our team as a Commissioning and Qualification Engineer and play a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities. In this role, you will generate test packages, coordinate and execute commissioning and qualification processes, and provide operational expertise.

Responsibilities:

Generate commissioning and qualification test packages or support others in generating respective documents. Coordination and execution of commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ) Carry out the commissioning and qualification within a plant environment. Including interacting with plant equipment and Upstream and Downstream Processes (USP/DSP) Create test plans for qualification, support and cooperation with QA Regularly reports the status of assigned work Brings operational experience during the commissioning and qualification phase Support automation engineers with operational know-how

Requirements:

Minimum 5 years of experience in commissioning and qualification of equipment in new pharmaceutical/biotech manufacturing facilities Hands-on process engineering and/or operational experience Good GMP skills for completing qualification documentation Prior knowledge of working on plants operated with an MES is preferable. Experience in plant planning, and project management with a focus on plant automation or projects in technical computer science Fluent in English

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