Advanced CQV Engineer - Clayton NC

About the role

As an Advanced CQV Consultant at NNE, you will lead commissioning, qualification, and validation activities across complex life sciences projects. Serving as a Project Quality Manager (PQM), you will drive quality, compliance, and validation strategies that meet client, industry, and regulatory requirements while collaborating with multidisciplinary teams to deliver successful project outcomes.

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.

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
• 8+ years of CQV, Quality, Validation, or GMP consulting experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience leading qualification and validation programs for GMP-regulated facilities.
• Experience as a Quality Lead, Validation Lead, or Project Quality Manager on complex projects.
• Strong knowledge of GMP regulations (FDA, EMA, ICH), GAMP 5, ASTM E2500, ISPE Baseline Guides, Quality Risk Management, Data Integrity, and Validation Lifecycle Management.

Preferred Qualifications

• Experience supporting large capital projects, clean utilities, process equipment, facilities, and automation systems.
• PMP, ASQ, ISPE, or similar professional certification.
• Client-facing consulting experience.

Benefits

• Competitive salary with annual adjustment increases
• 160 hours of PTO (prorated from hire date) + 14 paid holidays
• Health, dental, and vision insurance from day one
• 8% guaranteed 401(k) company contribution
• 14 weeks paid parental leave
• Company-paid life and disability insurance
• Employee referral bonuses