Senior CQV Validation Consultant

NNE; Clayton (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

PTO 160 hours

14 paid holidays

Health, dental, and vision insurance

8% 401(k) company contribution

Parental leave (14 weeks)

Life and disability insurance

Employee referral bonuses

Job summary

NNE in the United States seeks an Advanced Validation Consultant to plan, execute, and deliver commissioning, qualification, and validation activities across pharma and life sciences projects. You will work with multidisciplinary teams to ensure facilities, equipment, and processes meet GMP, regulatory, and client requirements.

The role combines hands-on CQV technical work with project quality management, risk assessment, and quality oversight.

Qualifications

• 5+ years of CQV, Quality, Validation, or GMP consulting experience in pharma/biotech.
• 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.

Responsibilities

• Support CQV activities for facilities, utilities, equipment, and computerized systems.
• Develop and review CQV lifecycle documentation (IQ/OQ/PQ, risk assessments, traceability matrices, reports).
• Execute qualification activities and ensure GMP compliance.
• Collaborate with engineering, automation, quality, and manufacturing teams.
• Identify and elevate project risks and compliance concerns.
• Align project quality strategies with client expectations and regulatory requirements.
• Support Quality Assurance Plans (QAPs), GMP, GEP, ASTM E2500 reviews, and design reviews.
• Act as a trusted advisor on quality and compliance matters.

Skills

CQV experience

Quality assurance

Validation

GMP consulting

Regulatory knowledge

Education

Bachelor's or Master's degree in Engineering/Life Sciences

Job description

NNE in the United States seeks an Advanced Validation Consultant to plan, execute, and deliver commissioning, qualification, and validation activities across pharma and life sciences projects. You will work with multidisciplinary teams to ensure facilities, equipment, and processes meet GMP, regulatory, and client requirements.

The role combines hands-on CQV technical work with project quality management, risk assessment, and quality oversight.