Director: Engineering, Facilities and Validation
, utilities, equipment, and computerized systems, ensuring compliant execution of IQ/OQ/PQ, periodic requalification, and change...
, utilities, equipment, and computerized systems, ensuring compliant execution of IQ/OQ/PQ, periodic requalification, and change...
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...
documentation, and regulated quality systems Experience supporting TMVs, PPAPs, IQ/OQ/PQ activities, or equipment validations...
more at Responsibilities: Responsible for IQ, OQ and PQ of equipment, including generation of initial protocol, execution and final report...
and audit-ready Supporting design transfer, process validation (IQ/OQ/PQ), and manufacturing scale-up efforts Participating...
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...
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...
process validation planning and execution. Assume full ownership of PQ process validation planning, execution, and reporting...