Cleaning Validation Subject Matter Expert
Stark Pharma Solutions Inc
Position: Cleaning Validation Subject Matter Expert
Location: Illinois
Duration: Long Term
Job Overview
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.
Key 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.
Required Qualifications
- 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.
- Strong critical-thinking and technical-writing skills.
- Strong communication, organizational, and cross-functional collaboration skills.
Vacancy posted 4 days ago
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