Advanced Quality / Validation Engineer
NNE · Clayton, NC · 4 days ago
On-siteQuality AssuranceInternship
About the role
The Advanced CQV Consultant is a senior-level validation and quality professional responsible for leading commissioning, qualification, and validation (CQV) 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.
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.
Qualifications
- Education: Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
- Experience & Knowledge: 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.