Cleaning Validation Subject Matter Expert

About the role

We are seeking an experienced Cleaning Validation Subject Matter Expert to lead cleaning validation activities in a GMP manufacturing environment. The role involves developing cleaning procedures, preparing and executing validation activities, troubleshooting cleaning-related issues, and providing technical expertise to support compliance with cGMP and FDA requirements.

Responsibilities

• Design and develop cleaning procedures for manufacturing equipment and new products.
• Provide technical support for manufacturing cleaning activities.
• Lead cleaning validation activities and programs.
• Support selection and use of cleaning agents and establish effective cleaning practices.
• Develop and implement cleaning strategies for product transfer and product development projects.
• Investigate cleaning-related deviations, incidents, and out-of-specification results.
• Perform root-cause analysis and troubleshooting for cleaning issues.
• Lead improvements to cleaning practices and review work instructions.
• Support periodic review of cleaning validation studies.
• Resolve incidents and deviations related to cleaning activities.
• Initiate and manage change controls for cleaning procedure changes.
• Collaborate with cross-functional teams to ensure timely completion of validation activities.

Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• 4+ years of experience in GMP manufacturing and cleaning validation.
• Strong knowledge of cleaning validation principles and practices.
• Experience with cleaning procedures, protocols, investigations, and change controls.
• Familiarity with FDA regulatory requirements and cGMP standards.
• Experience with continuous process improvement and equipment/process qualification.

Skills

• Strong critical-thinking and technical-writing skills.
• Strong communication, organizational, and cross-functional collaboration skills.

Location: Illinois
Duration: Long Term