Advanced Validation Engineer
NNE (Novo Nordisk Engineering) · nne.com
ClaytonMid level
Subscribers got this job on 11 October 2026.
New jobs reach them at 8 am and 6 pm, 5 days before they open here. Get the next one first
The job in short
Pharmaceutical CQV validation consultant supporting commissioning and qualification.
Compliance
Details
- Found
- 14 d ago · posted 2026-10-09
- Location as listed
- Clayton, NC, US
- Role
- Engineer (other)
- Source
- The company’s own careers site
Full description
About the job: The Advanced Validation Consultant is a mid-level validation and quality professional responsible for supporting commissioning, qualification, and validation activities across pharmaceutical and life sciences projects. This role combines hands-on technical expertise with Project Quality Management responsibilities, ensuring facilities, equipment, systems, and processes meet GMP, regulatory, and client requirements. Working closely with multidisciplinary teams and customer stakeholders, the consultant serves as a trusted advisor on validation strategy, compliance, risk management, and quality execution. The ideal candidate brings validation experience, leadership skills, and a passion for delivering high-quality, compliant project outcomes. Key Responsibilities CQV Execution Support 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. 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.
Engineer (other) jobs in the United States · All NNE (Novo Nordisk Engineering) jobs