in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software. General...
PQ meters. Programming of SEL, GE, PML, Schneider, etc. IEDs for integration. Programming of HMIs. Programming...
for single-use products. Formulate, carry out, and understand validation protocols (IQ, OQ, PQ). Review validation data, craft...
activities and processes. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities...
Project management and CAPEX execution Six Sigma Green/Black Belt and/or PMP Validation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV...
regulations within the E.U. and U.S. FDA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP...
the execution of FMEA, FAT, IQ/OQ, PQ and CQV processes to ensure robust project outcomes. Develop technical documentation...: Advanced degree in an engineering discipline Strong knowledge of qualification/validation methodologies (FMEA, FAT, IQ/OQ/PQ...
/OQ/DQ/PQ). Provide production line support for day-to-day engineering issues on core instrument lines i.e. resolve...
scripts, traceability matrices, and validation reports Execute IQ/OQ/PQ testing, risk assessments, data integrity (ALCOA... validation activities including IQ/OQ/PQ, requirements development, test execution, and traceability Familiarity...
design Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability...