Applied Laboratories is seeking a Cleaning Validation Engineer to develop, execute, and maintain cleaning validation programs within a GMP pharmaceutical manufacturing environment. This position is responsible for validation protocol development, hold-time studies, contamination control, data analysis, investigations, and regulatory compliance activities.
The Cleaning Validation Engineer will collaborate with Manufacturing, Quality, Microbiology, Engineering, and Validation teams to maintain compliant cleaning processes and support production readiness.
Essential Responsibilities
- Create and review cleaning validation protocols, risk assessments, validation reports, and master planning documents.
- Design and execute cleaning validation studies involving swab, rinse, total organic carbon (TOC), chemical, and microbiological sampling.
- Develop and justify acceptance limits using risk-based and scientifically sound 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, clean-in-place systems, contamination control, and troubleshooting activities.
- 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.
Qualifications
- Bachelor’s degree in a science or engineering discipline, or equivalent experience.
- Experience in a GMP-regulated pharmaceutical manufacturing environment.
- Strong knowledge of cleaning validation, contamination control, cleaning chemistry, and manufacturing processes.
- Experience conducting 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.
- Experience training and mentoring personnel is preferred.
- Ability to troubleshoot complex manufacturing cleaning systems is preferred.
Work Environment
This position may work in laboratory, manufacturing, production, warehouse, and office environments based on assigned responsibilities. The role requires compliance with safety, quality, cGMP, sanitation, and personal protective equipment requirements.
The position may involve standing, walking, bending, reaching, fine-motor work, lifting or carrying materials, and accessing production or warehouse areas. Employees may be exposed to noise, odors, powders, liquids, chemicals, and slippery surfaces.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.
Why Applied Laboratories?
At Applied Laboratories, we are committed to producing quality products while maintaining a safe, collaborative, and compliant workplace. This position offers the opportunity to apply scientific and engineering expertise, influence critical validation programs, and work across multiple functions to support reliable pharmaceutical manufacturing.