CQV (Commissioning, Qualification & Validation) Engineer

2 weeks ago


Carlsbad, United States Consultys Full time

Missions 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.

Coordinate and execute 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 report the status of assigned work

Bring operational experience during the commissioning and qualification phase

Support automation engineers with operational know-how

Missions Minimum 2 to 8 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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