MES Engineer
systems meet GxP and FDA 21 CFR Part 11 requirements. Author/execute technical validation documents (URS, FRS, DS, IQ/OQ/PQ...
systems meet GxP and FDA 21 CFR Part 11 requirements. Author/execute technical validation documents (URS, FRS, DS, IQ/OQ/PQ...
process qualification/validation using IQ, OQ, and PQ methodologies. Inspection & Test Method Validation: Define Receiving... industry. ISO 13485 Certified Talent preferred by client. Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans...
activities, including IQ/OQ/PQ documentation, test plans, and equipment commissioning. Partner with QA and Production to ensure...
continuous improvement initiatives. Performs or manages process validations (IQ/OQ, OQ, PQ). Perform Verification and Validation...
, protocols, and reports, Test Method Validation, as well as process validation activities (PFMEA, IQ, OQ, PQ) using statistical...
continuous improvement initiatives. Performs or manages process validations (IQ/OQ, OQ, PQ). Perform Verification and Validation...
and conduct Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) on equipment...
, write, and revise CQV documents including URS, DQ, IQ, OQ, PQ protocols and summary reports. Draft equipment and system...
knowledge of Validations, IQ, OQ, PQ, and DOE's is desirable. Consistent record of supporting and driving continuous...
of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process systems. Develop and implement validation...