Responsibilities:

1. Develop, maintain, and approve cleaning validation requirements ensuring compliance with regulatory and business standards
2. Own cleaning validation lifecycle activities including protocols, procedures, sampling strategies, and validation documentation
3. Review and approve cleaning procedures, inspection methods, and cleaning verification processes
4. Define testing strategies and ensure execution and documentation of cleaning validation programs
5. Support regulatory inspections, audits, and investigation activities related to cleaning validation
6. Conduct periodic reviews to ensure cleaning processes remain in a validated state
7. Revise and approve SOPs, work instructions, and cleaning-related documentation used in manufacturing operations
8. Lead development of swab sampling strategies and testing approaches for new and existing equipment
9. Support optimization and continuous improvement initiatives for cleaning processes and compliance effectiveness
10. Provide leadership, mentoring, and training to site personnel and Cleaning Validation team members on procedures and expectations

Requirements:

1. Bachelor’s Degree in Engineering, Chemistry, Life Sciences, or related field
2. Experience in Cleaning Validation within pharmaceutical or other regulated GMP manufacturing environments
3. Strong understanding of FDA, EU, and global cGMP regulatory requirements
4. Experience developing validation protocols, reports, and cleaning procedures across lifecycle phases
5. Experience supporting regulatory inspections, audits, and compliance investigations
6. Strong technical writing, documentation, and cross-functional communication skills
7. Experience with manufacturing equipment, cleaning systems, or validation lifecycle programs preferred