Solution Prep C&Q Lead

Solution Prep C&Q Lead - US, North Carolina - Long Term Contract 

Are you ready to make a real impact? Our client, a globally recognized leader in biotechnology, is hiring for the role of Solution Prep C&Q Lead. Known for their innovation and dedication to improving lives, they focus on tackling some of the most urgent medical challenges through cutting-edge science.

This is a great chance to be part of a major East Coast project, helping to develop breakthrough treatments that make a real difference to people’s health worldwide.

What you’ll do:

• Serve as the commissioning and qualification (C&Q) lead for Solution Prep systems
• Develop and optimize Solution Prep systems to meet operational and quality standards. Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.
• Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
• Engage with design engineers and SMEs to clarify system intent and operational requirements.
• Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation.

What you’ll need:

• Extensive experience advising on Solution Prep C&Q programs for large scale construction projects, with experience on projects ranging from.
• Background in greenfield construction, ideally with drug substance biologics or similar industries.
• Strong knowledge of Solution Prep equipment C&Q documentation and process design.
• Experience with development, execution, and reporting for C&Q activities for Solution Prep equipment

Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!
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