/PQ protocols, Test Scripts, Traceability Matrix, and Validation Summary Reports. Establish and enforce traceability... hands-on IQ/OQ/PQ execution and risk-based validation approaches. Strong working knowledge of GxP regulations, FDA 21 CFR...
and modeling software (e.g., Aspen Plus or SuperPro Designer). Experience with validation protocols, including IQ/OQ/PQ...
of experience in IQ, OQ & PQ validations. 5+ years of medical device experience Preferred Qualifications: Master’s Degree...
(OQ), and Performance Qualification (PQ) processes. Ensure sterilization and packaging meet regulatory standards... with IQ, OQ, and PQ validation processes. 3-5 years of experience in the medical device industry, preferred. Additional...
to corroborate equipment design and application to include (but not limited to) commissioning items, FAT, SAT, IQ/OQ/PQ, calibration...
: Includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ...
Chain). Support validation activities (IQ/OQ/PQ/PPQ, TMV, Process Characterization). Oversee production line startups...
design and procurement, and inspection plans. Coordinates and/or performs validation activities (IQ, OQ, PQ) designed...
product introductions and production scaling Perform process validations (IQ/OQ/PQ) Troubleshoot manufacturing issues...
protocols (IQ/OQ/PQ). Knowledge of laboratory-specific engineering systems including fume hoods, biosafety cabinets...