Lead CQV Validation Engineer - GMP/Life Sciences

NNE Inc.; Powhatan (NC); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

PTO 160 hours + holidays

Health, dental, vision insurance

401(k) company contribution

Parental leave

Life and disability insurance

Employee referral bonuses

Job summary

NNE Inc. is seeking an Advanced Validation Consultant to plan, execute, and deliver CQV activities across pharmaceutical and life sciences projects.

This mid-level role combines hands-on validation with project quality management to ensure facilities, equipment, and processes meet GMP and regulatory standards. You will collaborate with engineering, automation, and quality teams, develop IQ/OQ/PQ/PfV protocols, lead risk assessments, and mentor junior staff.

Qualifications

• 5+ years CQV, Quality, Validation, or GMP consulting in pharma/liife sciences.
• Experience with qualification and validation programs for GMP-regulated facilities.
• Knowledge of GMP regulations (FDA, EMA, ICH), GAMP 5, ASTM E2500, ISPE Baseline Guides, Data Integrity, and Validation Lifecycle Management.

Responsibilities

• Support CQV activities for facilities, utilities, equipment, and computerized systems.
• Develop and review CQV lifecycle docs: validation plans, risk assessments, IQ/OQ/PQ/PfV, traceability matrices, and summary reports.
• Execute qualification activities and ensure GMP compliance.
• Collaborate with engineering, automation, quality, and manufacturing teams across FAT, SAT, startup, and commissioning.
• Identify and elevate project risks and compliance concerns.

Skills

CQV

Quality

Validation

GMP

Regulatory knowledge

Education

Bachelor’s/Master’s in Engineering or Life Sciences

Job description

NNE Inc. is seeking an Advanced Validation Consultant to plan, execute, and deliver CQV activities across pharmaceutical and life sciences projects.

This mid-level role combines hands-on validation with project quality management to ensure facilities, equipment, and processes meet GMP and regulatory standards. You will collaborate with engineering, automation, and quality teams, develop IQ/OQ/PQ/PfV protocols, lead risk assessments, and mentor junior staff.