, design, integration, commissioning, CSV (IQ/OQ/PQ), and lifecycle support. Implement CAR‑T process changes..., and experience authoring IQ/OQ/PQ protocols and trace matrices. Demonstrated capability managing multi‑disciplinary projects...
, protocols (DQ, IQ, OQ, PQ) summary reports, and validation master plans/reports. As member of global engineering team, strongly...
&R and capability studies. Support the implementation of IQ, OQ, PQ documentation. Assist in the development...
experience. Author validation documents and records including IQ, OQ and PQ reports and protocols. Drive Design Control..., materials, manufacturing and quality including validations (IQ, OQ, PQ). Knowledge of applicable regulatory standards...
Qualification Protocols (PQ) Review and Approval of protocol discrepancies Review of Final Reports and Summary Documents Provide...
materials, product quality (PQ) script creation, Non-Product Software System (NPSS) validation, and the development of metrics...
devices Demonstrated experience in process design, validation (IQ/OQ/PQ), and production support Strong working knowledge...
timelines. o Commissioning / Qualification Protocols o Performance Qualification Protocols (PQ) o Review and Approval...
process validations (IQ/OQ/PQ) and the creation of statistically derived product specifications. Oversee and lead multiple...
and execution of qualification and validation protocols (Ex: IQ/OQ/PQ) protocols to ensure compliance with Master Validation Plans...