Senior Process Engineer
design Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability...
design Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability...
for equipment critical to infant formula safety, including qualification protocols (IQ/OQ/PQ) in compliance with FSSC 22000... in infant formula production. Expertise in validation protocols (IQ/OQ/PQ), cleaning validation, and software qualification...
, vendor selection, FAT/SAT execution, IQ/OQ/PQ, and production release. Troubleshoot mechanical, electrical, pneumatic.... Prior exposure to regulated environments (FDA and ISO 13485) and equipment qualification (IQ/OQ/PQ) is a plus. Knowledge...
validations (IQ/OQ/PQ) Create PPAP documentation Other duties as assigned MPI does not discriminate on the basis of race...
robust process qualification/validation using IQ, OQ, and PQ methodologies. Define Receiving Inspection requirements.... Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO 13485 standards. Excellent...
, and delivery. Execute validation and qualification ( IQ / OQ / PQ ) protocols for new products, equipment, tooling, and processes...
), and Performance Qualification (PQ) for manufacturing and laboratory equipment Conduct Configuration Specification Verifications... validation protocols including Validation Plans, URS, FRS, IQ/OQ/PQ, RTM, and Validation Summary Reports Ensure compliance...
Kia North America Ownership Experience - Product Quality (PQ) in supporting PQ Data Analytics Team and Service Engineering..., such as monthly top issues review, quarterly comeback analysis, monthly PQ operation reporting, and monthly quality information report...
expertise in CAPA management and process validations (IQ/OQ/PQ). Proven ability to oversee nonconformance handling, including...
, reviewing, and executing commissioning, IQ, OQ, and PQ protocols Verification of system installation, operation, controls... execution independently Strong understanding of IQ/OQ/PQ lifecycle Excellent technical writing and documentation skills...