(BSME preferred). Process Validation / IQ,OQ,PQ. Systems integration and Manufacturing process design. SPC / DOE...
experience important. The work is specifically performing Cycle Development and PQ/PV on equipment. Heavy experience with IQ, OQ... and PQ of autoclaves and parts washers would work as well. Project is very schedule driven with mostly overnight shifts...
validation protocols such as: o Process validation (OQ/PQ where applicable) o Equipment qualification (IQ/OQ... in cross-functional teams. Preferred Qualifications Experience with manufacturing validation methods (e.g., IQ/OQ/PQ...
, and report on manufacturing validation and verification activities, including design transfer, IQ, OQ, PQ, process validation...
assembly and test processes, including IQ/OQ/PQ and equipment qualification. Apply Built-in Quality principles...-yoke, throughput, utilization, and process capability. Skilled in PFMEA, control plans, process validation (IQ/OQ/PQ...
, or addition of new tool models. Verify all service documentation (e.g. PMC, IQ/OQ/PQ, MPIs, etc.) related to field service tools...
to improve operational efficiency and throughput. Develop and execute process validation protocols, including IQ, OQ, and PQ...
more at Responsibilities: Responsible for IQ, OQ and PQ of equipment, including generation of initial protocol, execution and final report...
Plans IQ/OQ/PQ Protocols Test Scripts Traceability Matrices Functional Specifications Discrepancy Reports Summary Reports... including FAT, SAT, IQ, OQ, PQ, and automation functional testing. Document test execution results, discrepancies, deviations...
and audit-ready Supporting design transfer, process validation (IQ/OQ/PQ), and manufacturing scale-up efforts Participating...