Manufacturing Engineer II
. Equipment Validations experience is needed. Exp with IQ, OQ, PQ. Executing and writing validation protocols...
. Equipment Validations experience is needed. Exp with IQ, OQ, PQ. Executing and writing validation protocols...
, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality...
with safety rules and regulations. Follow standard operating procedures (SOP). Participate in IQ/OQ/PQ for equipment to ensure...
-certified quality systems and GD&T standards. - Experience in validations (e.g., TMV, GRR, OQ/PQ). - Ownership of data metrics...
, and Test Method Validation (IQ/OQ/PQ/TMV), manufacturing documentation, process risk mgmt. & failure mode and effect analysis...;Design & manufacturing transfer of pilot line, including IQ/OQ/PQ/TMV, Process Risk Mgmt. & FMEA, process and production...
validations with a focus on process characterization Operational Qualification and Performance Qualification (OQ/PQ) per ISO11607... validations PV & OQ/PQ per ISO11607-2;and Packaging deliverables for regulatory submission and sterilization optimization...
include: User Requirement Specifications Commissioning IQ, OQ, PQ Calibration Standard Operating Procedures...
implantation. Drive validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling and processes...
validation, IQ, OQ, and PQ road map requirements. Proven interpersonal and communication skills, with the ability to work...
timelines, costs, capital, expense, risk and recommendations Responsible for validations, IQ/OQ/PQ, product production...