Validation Engineer 2
San Diego, California, United States
New Product Intro (NPI) Validation Engineer - Research Use Only (RUO)Key Projects: NovaSeq X & NextSeq1000/2000 product linesSupports strategic planning for pipeline validation activities, performs validation assessments for incoming systems/processes against pre-existing systems/processes to determine scope of validation work, generates process validation master plans (PVMPs), supports development of user requirement specifications (URS), functional specifications (FS), configuration… Show more New Product Intro (NPI) Validation Engineer - Research Use Only (RUO)Key Projects: NovaSeq X & NextSeq1000/2000 product linesSupports strategic planning for pipeline validation activities, performs validation assessments for incoming systems/processes against pre-existing systems/processes to determine scope of validation work, generates process validation master plans (PVMPs), supports development of user requirement specifications (URS), functional specifications (FS), configuration specifications (CS), and system requirement risk assessments (SRAs) for new system onboarding. Works with cross functional teams to document critical process parameters (CPPs) and critical quality attributes (CQAs) to support process validation. Authors validation protocols, coordinates and/or performs executions, authors qualification summary reports (QSRs) and process validation master plan reports (PVMP-Rs). Ensures smooth transition of NPI program(s) to sustaining teams.Sustaining Validation Engineer - Quality Control (RUO and IVD)Maintains the validated state of Illumina’s Reagent Quality Control area including RUO and Dx sequencer fleet. Supports development of URS, FS, CS and SRAs for new system onboarding. Authors validation protocols, coordinates and/or performs executions and authors QSRs. Maintains area validation master plans and reports. Performs validation impact assessments prior to implementation of changes. Supports migration of validation packages into electronic validation lifecycle management software (ValGenesis). Performed validation lifecycle monitoring activities through equipment periodic review. Created and piloted a validation mentorship program Show less