The Validation Engineer coordinates qualification activities of consumables parts used in Cepheid GeneXpert cartridges and SmartCycler tubes under the supervision of a Senior Validation Engineer. This person will work with a team that includes Consumables Engineers, Manufacturing Process Development Engineers, and a Supply Chain Coordinator to plan and execute the development and qualification activities required to maintain the consumables parts supply chain and ensure the quality and consistency of Cepheid products.
Work under the supervision of the Sr. Validation Engineer to conduct following activities to maintain supply of consumable parts used in Cepheid GeneXpert cartridges and SmartCycler tubes:
- Draft and execute the qualification protocols
- Coordinate manufacturing events for qualification activities
- Perform or coordinate analytical testing with Manufacturing Engineering, Manufacturing and/or QC groups
- Conduct statistical data analysis and draft reports
- Update bill of materials (BOM) as needed
- Initiate change orders and oversee their completion
- Execute implementation plan and work with Manufacturing and Materials Planning for smooth implementation and rollout of newly qualified parts.
- Work under the supervision of the Sr. Validation Engineer to:
- Perform additional testing to assess variations between existing and new molding tools and any impact to assay performance.
- Perform experiments for analysis of variance (ANOVA) of assay performance from molding tools, automation tools, lot to lot variation, assay effect, and test modules, etc.
- B.S. degree in Engineering, Bio-Engineering, or Life Science disciplines.
- Minimum of 0-1 years with a B.S. degree.
- Previous Manufacturing or Manufacturing Development experience in medical devices, biotech, and/or pharmaceutical industries is a plus.
- Experience with validation activities such as equipment qualification (IQ, OQ, and PQ), process qualification (PPQ or PV), and supplier qualification is a plus.
- Familiar with MiniTab, JMP, or other statistical data analysis software is a plus.
- Experience and ability to run basic bio assays and perform lab work is a plus.
- Experience with QSR system and ability to work within a regulated environment is a plus.
- Ability to work effectively with project team members from different functions.
- Detailed oriented and ability to handle multiple projects simultaneously.
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