Senior Manufacturing Engineer
validations in accordance with Master Validation Plans, including IQ, OQ, PQ, Gauge R&R, and software validation. Analyze...
validations in accordance with Master Validation Plans, including IQ, OQ, PQ, Gauge R&R, and software validation. Analyze...
both within and outside of AbbVie. Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV. Mentor/lead product team...
Specific experience with process characterization, equipment IQOQ, process OQ, and PQ Specific experience with Test method...: Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure...
, DQ, IQ, OQ, PQ protocols as well as summary reports. Lead and document troubleshooting efforts of issues encountered...
both within and outside of AbbVie. Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV. Mentor/lead product team...
, validation, qualifications (IQ, OQ, PQ) and root cause – corrective action. Support a culture of Operational Excellence...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
) to validate and improve products and establish robust manufacturing processes;ensure completion of process validations (IQ/OQ/PQ...
and equipment qualification (IQ/OQ/PQ), media fills, cleaning validation, and lifecycle process management. Proficiency...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...