Senior Cleaning Validation Engineer for CQV & CIP/COP

MedPharm Ltd; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

MedPharm Ltd. is seeking a Cleaning Validation Engineer to lead site‑wide validation programs across product lifecycles, ensuring cGMP and FDA compliance in a multi‑product facility.

You will drive CVMP development, risk‑based approaches, and robust validation strategies for CIP, COP, and manual cleaning. The role emphasizes inspection readiness, data analysis, and collaboration with Manufacturing, QA, and Regulatory teams.

Qualifications

• Bachelor’s or Master’s degree in Engineering or related discipline.
• 5–8+ years of experience in cleaning validation and CQV in pharma/biopharma/CDMO environments.
• Experience supporting regulatory inspections and lifecycle cleaning validation programs.

Responsibilities

• Develop and maintain the Cleaning Validation Master Plan (CVMP) aligned with FDA, ICH Q9, EU Annex 1.
• Lead CQV activities for CIP, COP, and manual cleaning systems.
• Design and execute validation studies (swab/rinse sampling, recovery studies).
• Develop risk‑based sampling strategies and worst‑case scenarios.
• Ensure ongoing compliance through trend analysis, inspections support, and CAPA management.

Skills

Cleaning Validation

CIP/COP

Risk assessment

DOE

Regulatory knowledge

Education

Bachelor’s or Master’s in Engineering

Tools

IQ/OQ/PQ

WFI/clean steam

Job description

MedPharm Ltd. is seeking a Cleaning Validation Engineer to lead site‑wide validation programs across product lifecycles, ensuring cGMP and FDA compliance in a multi‑product facility.

You will drive CVMP development, risk‑based approaches, and robust validation strategies for CIP, COP, and manual cleaning. The role emphasizes inspection readiness, data analysis, and collaboration with Manufacturing, QA, and Regulatory teams.