GMP Cleaning Validation Engineer – Drive Contamination Control

Applied Laboratories, Inc.; Columbus (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Applied Laboratories is seeking a Cleaning Validation Engineer to develop, execute, and maintain cleaning validation programs within a GMP pharmaceutical environment. You will collaborate with Manufacturing, Quality, Microbiology, Engineering, and Validation teams to maintain compliant cleaning processes and support production readiness.

The role requires designing validation studies, establishing acceptance limits, and leading change-control activities while ensuring FDA/EMA compliance.

Qualifications

• Bachelor's degree in science or engineering; GMP experience preferred.
• Experience in GMP-regulated pharmaceutical manufacturing.
• Strong knowledge of cleaning validation, contamination control, and cleaning chemistry.
• Experience with dirty hold-time, clean hold-time, and sanitization hold-time validation studies.
• Knowledge of swab, rinse, TOC, chemical, and microbiological testing methodologies.
• Experience with risk assessments, matrix validation approaches, and worst-case product evaluations.
• Ability to perform data analysis, root-cause investigations, and CAPA development.
• Knowledge of FDA, EMA, Annex 1, and industry guidance related to cleaning validation.
• Excellent communication, technical writing, and project-management skills.
• Experience supporting regulatory inspections and audits is preferred.

Responsibilities

• Create and review cleaning validation protocols, risk assessments, validation reports, and master planning documents.
• Design and execute cleaning validation studies involving swab, rinse, TOC, chemical, and microbiological sampling.
• Develop and justify acceptance limits using risk-based methodologies.
• Perform dirty hold-time, clean hold-time, and sanitization hold-time studies and establish validated operating limits.
• Compile, analyze, trend, and report validation data.
• Investigate deviations, out-of-specification results, and cleaning failures.
• Provide technical support for cleaning process improvements and contamination control.
• Support recovery studies, analytical method suitability, and validation of cleaning verification methods.
• Lead change-control assessments, periodic reviews, and continued verification of validated cleaning processes.
• Collaborate with Manufacturing, Quality, Microbiology, Engineering, and Validation teams to maintain compliance and production readiness.
• Support regulatory inspections, customer audits, corrective and preventive action activities, and responses to audit observations.
• Review equipment designs and qualification activities to support cleanability and contamination prevention.
• Ensure compliance with FDA, EMA, GMP, and company quality-system requirements.

Skills

Cleaning validation

Data analysis

Technical writing

Project management

Communication

Education

Bachelor's degree in science or engineering

Job description

Applied Laboratories is seeking a Cleaning Validation Engineer to develop, execute, and maintain cleaning validation programs within a GMP pharmaceutical environment. You will collaborate with Manufacturing, Quality, Microbiology, Engineering, and Validation teams to maintain compliant cleaning processes and support production readiness.

The role requires designing validation studies, establishing acceptance limits, and leading change-control activities while ensuring FDA/EMA compliance.