Advanced Validation Engineer

NNE•Clayton, NC

12d•Onsite

About The Position

As an Advanced Validation Consultant, you are responsible for the planning, execution, and delivery of commissioning, qualification, and validation activities within pharmaceutical, biotechnology, and life science projects. 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.

Requirements

Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
5+ years of CQV, Quality, Validation, or GMP consulting experience within the pharmaceutical, biotechnology, or life sciences industry.
Experience with qualification and validation programs for GMP-regulated facilities.
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

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.
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.