principles Knowledge of GD&T Knowledge of DFMEA and PFMEA Validation;OQ, IQ, PQ, TMV Knowledge of Design for Automation...
and execute engineering studies, DOE protocols, and IQ/OQ/PQ documentation. Provide advanced technical support...
appropriate testing (i.e., FAT, SAT, UAT, IQ, OQ, PQ, &/or GEP) is in place to ensure IT requirements are met Participates...
actions during ramp-up and steady-state production. Process Development & Validation: Execute IQ/OQ/PQ validation...
translation into executable recipes. Ability to define URS/FRS and support testing (IQ/OQ/PQ, UAT). Ability to architect...
with Lean Manufacturing principles and work cell layout design Experience with equipment qualification protocols (IQ, OQ, PQ...
: Computer System Validation (CSV) Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ...
) Verify scope, strategy, and acceptance criteria Execute IQ/OQ/PQ protocols supporting commissioning of MES, Client... specifications Review SAT and FAT documentation Review IQ/OQ/PQ protocols for URS alignment and accuracy Ensure compliance with 21...
, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports). Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR...
and qualification plans (MVP, IQ/OQ/PQ) for supplier execution. Prepare assembly instructions, BOMs, and process documentation... analysis, and GD&T. Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports...