To provide validation support to Immunotherapy Production, Quality Control, and Plant Engineering. Provide activity update to Department Manager,Validation Services on a regular basis to ensure compliance issues are being met. Interact with FDA investigators regarding validation compliance issues and regulatory requirements. Develop, write and excite equipment, cleaning and utility system validations for product manufacturing and support processes. Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, and P&Ids, as they relate to validation and regulatory compliance issues. Coordinate validation activities with appropriate departments and contract validation firm employees.
Ability to coordinate and complete complex projects; excellent written and oral communication and presentation skills; computer literate in word processing and data entry; extensive experience with Kaye Digistrip and Validator 2000; excellent problem solving skills, detail oriented, and excellent mathematical and advanced statistical analysis skills. Requires extensive reporting such as Validation IQ/OQ/PQs and Validation Final Reports, Project Planning and Annual Evaluation and Operational Assessment Reports of Critical System and Equipment.
Bachelor’s degree in Science or Engineering. Five to seven years validation experience in a cGMP, pharmaceutical/biological manufacturing environment.