Job Title: C&Q Subject Matter Expert (SME)
Location: Onsite, Holly Springs, NC
Duration: 6 20 months (Contract)
Experience: 5 - 7 Years
Our client, a global biotechnology leader specializing in general medicine, rare diseases, inflammation, and oncology, is seeking experienced Commissioning and Qualification (C&Q) Subject Matter Experts . This role requires deep expertise in C&Q, with the ability to lead projects from initial workstream buildout through validation.
Key ResponsibilitiesBuild, manage, and execute full C&Q workstreams.
Fully own 2 3 systems or equipment packages through to validation readiness.
Lead cross-functional teams, working closely with engineering, quality, and project leadership.
Develop, write, and execute FATs, protocols, and related documentation.
Provide clear, detailed updates and status reports to leadership.
Expert-level knowledge of the full C&Q lifecycle, from commissioning through validation.
Proven experience owning and delivering multiple packages from start to validation.
Hands-on downstream purification experience .
Strong communication and leadership skills.
Experience with solution preparation, equipment process, and chromatography.
Ability to confidently lead teams and present to stakeholders.
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