Lead Validation Engineer
the planning, execution, and documentation of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process...
the planning, execution, and documentation of C&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process...
&Q lifecycle activities (URS, DQ, IQ, OQ, PQ) for automation and process systems. Develop and implement validation...
to Functional Requirements, Standard Operating Procedures, GXP Assessments for QC measurement systems. 4. Manages the IQ/OQ/PQ...
but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ...
, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs...
. Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols....
, and integrations. Develop and review Validation Master Plans (VMPs), Validation Protocols (IQ, OQ, PQ), and Test Scripts in compliance...
best practices. Develop IQ, OQ, and PQ methodologies for new equipment and process builds. Assist in training operators...
), operational qualification (OQ), performance qualification (PQ), and validation protocols. Provide quality presence...
quality, performance, and cost targets. Lead process validation (IQ, OQ, PQ) to ensure compliance with FDA QSR, ISO 13485...