Key Responsibilities
* Support validation activities for GMP equipment, facilities, and systems, ensuring ongoing compliance and validation status
* Review qualification protocols, reports, and validation documents, providing technical guidance and approval
* Perform change control assessments related to GMP systems and equipment, verifying regulatory adherence
* Develop validation protocols based on validation plans, ensuring clear and effective documentation
* Oversee validation review processes to confirm systems remain in a validated state throughout their lifecycle
* Manage documentation within systems such as DMS, LIMS, Kneat, and Trackwise, ensuring accuracy and traceability
* Contribute to the review and approval of SOPs, deviations, CAPAs, and other quality records
* Schedule and prioritize tasks independently, supporting validation and qualification activities
* Demonstrate a solid understanding of cell and gene therapy manufacturing equipment and validation procedures, including IQ, autoclaves, clean utilities, temperature mapping, and controlled storage validation
* Perform additional duties related to quality systems and validation activities as needed