Cleaning Validation Engineer SME

Role Summary

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

Responsibilities

• Design and manage Cleaning Validation activities at the site following a Lifecycle Approach, including authoring Cleaning Validation Protocols and Reports.
• Lead Cleaning Risk Assessments related to new product introductions and changes to existing products, materials, processes, and systems.
• Design, plan, and execute cleaning trials; analyze results and provide technical assessments, conclusions, and recommendations.
• Author and maintain the Cleaning Validation Master Plan for the Site.
• Lead periodic cleaning validation monitoring at the site.
• Benchmark against broader GSK GMS and external industry standards to achieve best-in-class practices and share knowledge across the network.
• Participate on assigned teams 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.
• Present Cleaning Validation documentation during Internal and External Regulatory inspections and prepare responses to deficiency reports.

Qualifications

• Required: Bachelor’s 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: Passion for innovation and driving process improvements.
• 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 cleaning validation
• Regulatory inspections and deficiency responses
• Process improvement and project management

Education

• Bachelor’s degree in engineering, chemistry, microbiology, or a related field.