Cleaning Validation Subject Matter Expert

Stark Pharma Solutions Inc; Chicago (IL); On-site; USD 95,000 - 135,000; Full time

Job summary

Stark Pharma Solutions Inc in Illinois seeks an experienced Cleaning Validation Subject Matter Expert to lead cleaning validation activities in a GMP manufacturing environment. You will develop cleaning procedures, plan and execute validation activities, and provide technical expertise to ensure compliance with cGMP and FDA requirements.

You will collaborate with cross-functional teams, investigate deviations, perform root-cause analysis, and drive continuous improvement of cleaning practices

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.

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.

Skills

GMP manufacturing

Cleaning validation

Technical writing

Cross-functional collaboration

Critical thinking

Process improvement

Verification and troubleshooting

Regulatory awareness

Education

Bachelor's degree in Engineering/Science

Job description

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.