Job Title: Sr Process Engineer
Reports To: Director, Sequencing Operations and Reagent Manufacturing
Department: Reagent Manufacturing
Location: Mountain View, CA transitioning to San Jose, CA
Complete Genomics is currently seeking a highly motivated Senior Process Engineer to join its Operations team. The role will be in support of the Reagent Manufacturing, Filling and Packaging departments, contributing to the commercialization of consumables for our next generation DNA sequencing platform. This exciting position provides an opportunity to contribute to CGI’s goal of improving human health by providing researchers and clinicians with the core technology and commercial systems to understand, prevent, diagnose, and treat diseases and conditions.
Major Duties and Responsibilities
- Lead product scale-up, process optimization, technology transfer, and equipment/process validation activities, as related to the Formulation, Filling, Labeling, and Packaging of CGI’s consumable Reagents. Will help to develop and qualify robust, high quality, and cost effective processes for manufacturing of these products.
- Responsible for process and equipment validation, including developing protocols, execution, and generating reports.
- Will be responsible for leading and/or contributing in cross-functional teams consisting of Manufacturing, R&D, Quality, Procurement, Equipment Services, Hardware Engineering and others. Perform project management functions to effectively drive results, manage project schedules, and communicate project status, experimental plans and results. Position may require interaction with other global manufacturing sites or contract manufacturing partners.
- Drive implementation through manufacturing, including setting up infrastructure, production documentation, and training on new processes and equipment.
- Ensure manufacturability of operations as it pertains to the utilization of staffing, facility (layout, etc.), materials, and equipment.
- Work with development and hardware engineers to establish equipment/instrumentation requirements and specifications. Interfaces with vendors on procurement, installation, maintenance, etc.
- Responsible for ongoing technical support of sustaining operations, including troubleshooting of equipment and process problems.
- Generate various documentation such as process flow diagrams, operating procedures, work instructions, equipment SOP’s, validation plans, reports and protocols.
- Conform to requirements for Design Control. Perform design and process risk assessments, such as pFMEA. Conduct design reviews.
- Apply working knowledge of Lean/Six Sigma principles in manufacturing, utilizing various tools (VSM, 5S, Kaizen, Visual Controls, etc.) to drive Continuous Improvement efforts. Develop metrics and controls to drive manufacturing improvements in the areas of cost, quality, yield, safety, and TAT.
- May be required to perform other related duties as required and/or assigned.