Advanced Validation Engineer
NNE
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- Location
- Clayton, United States
- Job type
- Full time
- Posted
- Oct 13
- 7 days ago
Career path
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About the company
NNE
Civil engineering · 1,001 to 5,000 employees
What you'll do
- Support CQV activities and develop and review lifecycle documentation for facilities, equipment, systems, and processes.
- Provide project quality oversight and client guidance, manage risks and quality outcomes, and mentor junior consultants.
What you need
- The ideal candidate brings validation experience, leadership skills, and a passion for delivering high-quality, compliant project outcomes.
Key skills
commissioning, qualification, and validationProject Quality ManagementGMPrisk managementvalidation strategyIQ/OQ/PQ/PfV protocolsrisk assessmentstraceability matricesGMP regulationsASTM E2500FATSATQuality Assurance Plansleadership skillsvalidation experience
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Read the full posting here
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 ExecutionSupport 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 SupportBuild 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.