Advanced CQV Engineer - Clayton NC

NNE•Clayton, NC

7d•Onsite

About The Position

At NNE, we help pharmaceutical and biotech companies design and deliver the facilities and processes that improve lives. As an Advanced CQV Consultant, 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. Primary Duties and Responsibilities: 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.

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.
Unrestricted authorization to work in the United States and must not require current or future sponsorship to maintain that authorization.

Nice To Haves

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

Responsibilities

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.
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.
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.