Advanced CQV Engineer - Clayton NC

As an Advanced CQV Consultant, you are responsible for planning, executing, and delivering commissioning, qualification, and validation (CQV) activities for pharmaceutical, biotechnology, and life sciences projects. Serving as the Project Quality Manager (PQM) on assigned projects, you ensure validation strategies, quality processes, and compliance requirements align with customer expectations, industry standards, and regulatory requirements. This role provides technical leadership throughout the validation lifecycle while supporting multidisciplinary project teams and client stakeholders. Key Responsibilities CQV Execution Lead commissioning, qualification, and validation (CQV) activities for facilities, utilities, equipment, and computerized systems. Develop and review CQV lifecycle documentation, including validation plans, risk assessments, IQ/OQ/PQ/PfV protocols, traceability matrices, and summary reports. Execute qualification activities, troubleshoot technical and compliance challenges, and ensure compliance with GMP regulations, industry standards, and company procedures. Collaborate with engineering, automation, quality, and manufacturing teams while supporting FAT, SAT, startup, and commissioning activities. Identify and escalate project risks, scope changes, and compliance concerns. Project Quality Management Serve as Project Quality Manager (PQM) on small to mid-sized projects, defining and managing validation and quality deliverables. Align project quality strategies with client expectations and regulatory requirements, while monitoring budgets, resources, risks, and quality outcomes. Support Quality Assurance Plans (QAPs), facilitate GMP, GEP, ASTM E2500, and design reviews, and provide quality oversight across project disciplines. Act as a trusted advisor to both project teams and clients on quality and compliance matters. Client, Leadership Business Support Build strong client relationships and provide technical guidance on CQV and validation strategies. Support proposals, project planning, cost estimates, and business development activities. Present project progress, risks, and mitigation plans to stakeholders and leadership. Mentor junior consultants, promote validation and quality best practices, and contribute to knowledge-sharing and continuous improvement initiatives.