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.