Cleaning Validation Engineer SME

Role Summary

Cleaning Validation Engineer SME at GSK in Zebulon, NC. Responsible for developing and implementing cleaning validation strategies to ensure site processes meet cleanliness and regulatory requirements, maintaining audit-ready state, and contributing to continuous improvement across operations.

Responsibilities

• Design and manage Cleaning Validation activities at the site following a Lifecycle Approach including the authoring of Cleaning Validation Protocols and Reports.
• Lead Cleaning Risk Assessments related to new product introduction and changes to existing products, materials, processes and systems.
• Design, plan and execute cleaning trials, analyze results and provide technical assessment, conclusions and recommendations.
• Author and maintain the Cleaning Validation Master Plan for the Site.
• Lead the periodic cleaning validation monitoring at the site.
• Benchmark against broader GSK GMS and external industry with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network to achieve excellence in Cleaning Validation.
• Participate on assigned teams as required to provide Cleaning Validation Impact Assessments and guidance.
• Review and coordinate Change Controls with Cleaning Validation impact as required.
• Lead and support continuous improvement by identifying and implementing projects to eliminate waste and improve cleaning times.
• Participate in teams to present Cleaning Validation documentation during Internal and External Regulatory inspections and prepare responses to deficiency reports.

Qualifications

• Bachelor’s degree in engineering, chemistry, microbiology, or a related field.
• 5+ years of experience in cleaning validation within a regulated manufacturing environment.
• Knowledge of cleaning validation principles, regulatory guidelines, and industry standards.
• Experience with risk assessments and validation documentation.
• Preferred: Advanced degree in a relevant field.
• Preferred: Familiarity with lean manufacturing and continuous improvement methodologies.
• Preferred: Previous experience supporting regulatory audits and inspections.
• Preferred: Strong organizational skills and ability to manage multiple projects simultaneously.
• Preferred: Excellent problem-solving skills and attention to detail.
• Preferred: Effective communication and collaboration skills to work across teams.

Skills

• Cleaning validation principles
• Risk assessment and validation documentation
• Lifecycle approach to validation
• Process improvement and analytics
• Cross-functional collaboration

Education

• Bachelor’s degree in engineering, chemistry, microbiology, or a related field.
• Advanced degree (preferred).

Additional Requirements

• On-site in Zebulon, NC.
• Ability to participate in regulatory inspections and respond to deficiency reports.