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.

• 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

• 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