Cleaning Validation

• Serve as the Cleaning Validation SME for the aseptic fill-finish facility, providing expert guidance on all aspects of cleaning validation.
• Develop, implement, and maintain Cleaning Validation Master Plans (CVMPs) in accordance with FDA, EMA, and global regulatory requirements.
• Design and execute cleaning validation and verification protocols, including worst-case product assessments, equipment train evaluations, and sampling strategies.
• Lead risk assessments related to cleaning validation, such as MACO (Maximum Allowable Carryover) calculations and cleaning limits.
• Oversee the execution and documentation of cleaning validation studies, including swab/rinse sampling, analytical method support, and final report generation.
• Collaborate with cross-functional teams including manufacturing, quality assurance, engineering, and analytical development to ensure cleaning validation activities are aligned with overall site and regulatory strategy.
• Provide training and mentorship to validation and QA personnel on cleaning validation principles and practices.
• Support regulatory inspections and audits as the site expert in cleaning validation.
• Stay current with industry guidance (e.g., PDA, ISPE, FDA, EMA) and integrate changes into site procedures and strategies.

Preferred Qualifications:

• Experience with compound or highly potent APIs and their impact on cleaning strategies.
• Experience with automated cleaning systems (CIP/SIP) and manual cleaning processes.
• Prior involvement in regulatory inspections related to cleaning validation.