The Senior Validation Engineer leads and coordinates qualification activities of consumables parts used in Cepheid GeneXpert cartridges and SmartCycler tubes. 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.
Lead and coordinate qualification activities required to maintain supply of consumable parts used in Cepheid GeneXpert cartridges and SmartCycler tubes:
- Develop qualification strategies and draft 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
- Develop implementation plan and work with Manufacturing and Materials Planning for smooth implementation and rollout of newly qualified parts.
- Perform additional testing to assess variations between existing and new molding tools and any impact to assay performance.
- Design and execute 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 or Bio-Engineering disciplines
- Minimum of 8 years (B.S. degree) or 5 years (M.S. degree) of Manufacturing or Manufacturing Development experience in medical devices, biotech, and/or pharmaceutical industries
- Extensive experience with validation activities such as equipment qualification (IQ, OQ, and PQ), process qualification (PPQ or PV), and supplier qualification
- Strong in Engineering Statistics & Data Analysis, Measurement System Analysis, and Design of Experiment (DOE)
- Experience and ability to run basic bio assays and perform lab work
- Experience with QSR system and ability to work within a regulated environment
- Ability to work effectively with project team members from different functions
- Detailed oriented and ability to handle multiple projects simultaneously
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