Senior Cleaning Validation Engineer - CQV Leader

MedPharm; Durham (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

MedPharm is seeking a Cleaning Validation Engineer to lead and govern the site-wide cleaning validation program across the product lifecycle, ensuring cGMP, FDA, and global regulatory compliance. The role provides technical leadership, risk-based strategy, and operational discipline to maintain inspection readiness and prevent cross-contamination in a multi-product environment.

As SME for CIP, COP, and manual cleaning, you will drive robust validation strategies aligned with client expectations

Qualifications

• Subject matter expertise in Cleaning Validation (CIP, COP, manual cleaning) and lifecycle validation.
• Strong knowledge of regulatory requirements (FDA, cGMP, ICH Q9, ASTM E2500, EU Annex 1, GAMP 5, ALCOA+)
• MACO & PDE calculations and toxicological risk assessments
• Cleaning cycle development, optimization, and troubleshooting
• Swab and rinse sampling strategies and recovery studies
• Cross-contamination control in multi-product facilities

Responsibilities

• Develop and maintain the Cleaning Validation Master Plan (CVMP) in alignment with FDA, ICH Q9, ASTM E2500, and EU Annex 1
• Lead CQV activities for CIP, COP, parts washers, and manual cleaning systems
• Design and execute validation studies (swab/rinse sampling, recovery studies, riboflavin coverage)
• Investigate failures and implement CAPAs; apply DOE to improve processes
• Support inspections, audits, and lifecycle management of cleaning validation programs
• Train staff and mentor junior engineers on cleaning validation practices

Skills

Cleaning Validation

Regulatory compliance

GMP knowledge

Risk-based sampling

IQ/OQ/PQ

Data analysis & trending

Education

Bachelor's or master's degree in engineering

Job description

MedPharm is seeking a Cleaning Validation Engineer to lead and govern the site-wide cleaning validation program across the product lifecycle, ensuring cGMP, FDA, and global regulatory compliance. The role provides technical leadership, risk-based strategy, and operational discipline to maintain inspection readiness and prevent cross-contamination in a multi-product environment.

As SME for CIP, COP, and manual cleaning, you will drive robust validation strategies aligned with client expectations