CQV Engineer

7 days ago

Portland, United States PES International Full time
Job DescriptionJob Description

CQV Engineer 
Cell and Gene Therapy Facility

Company: PES International 
Location: Portland, Oregon 
Compensation: Commensurate with Experience  
 
About this opportunity:  

PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled knowledge based in these specialist areas from initial concept design through to commissioning and qualification of your facility. We’re actively building out our US presence and looking for talented team members to work with us in delivering critical project management consultancy expertise.  

This role will be responsible for ensuring that all systems, facilities, and equipment are installed properly and meet the design requirements put in place for the end-users in a pharmaceutical facility (laboratory and manufacturing). This is a specialized processing facility that will require strong CQV experience in the Cell and Gene Therapy space. The CQV engineer will document the process of installation, operations, and how the equipment performs. 

What we’re looking for:  

  • 7+ years of experience in commissioning, qualification and validation in pharma or biotech industries  

  • Cell and Gene Therapy CQV Experience Required 

  • Experience in the areas of design documentation, validation (IQ/OQ/PQ, etc.), quality systems, and equipment startup 

  • Able to collaborate with cross-functional team members including engineering, quality, and manufacturing to develop and support comprehensive CQV strategies and plans for the pharmaceutical project  

  • Ability to support site validation planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, cleaning, packaging processes 

  • Work and interact with cross-functional team members  

  • Problem solving and troubleshooting ability 

  • High attention to detail  

  • Strong written and verbal communication skills interacting with variety of customers, vendors, equipment suppliers, and other team members 

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