Cleaning Validation Engineer SME

Role Summary

Cleaning Validation Engineer SME at GSK, focusing on maintaining audit-ready cleaning validation at the Zebulon site and ensuring compliance with local and global regulatory requirements. Develop and implement cleaning validation strategies, collaborate with cross-functional teams, and contribute to continuous improvement of 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

• Required: Bachelor‚Äôs degree in engineering, chemistry, microbiology, or a related field.
• Required: 5+ years of experience in cleaning validation within a regulated manufacturing environment.
• Required: Knowledge of cleaning validation principles, regulatory guidelines, and industry standards.
• Required: 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 and lifecycle approach
• Risk assessment and validation documentation
• Regulatory inspections support and audit readiness
• Project management and continuous improvement
• Cross-functional collaboration and communication

Education

• Bachelor‚Äôs degree in engineering, chemistry, microbiology, or related field
• Advanced degree (preferred)