Senior Process and Automation Engineer, Reagent Production

At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing deep, hard science with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines. We are hiring for a Senior Process and Automation Engineer, Reagent Production to join our growing team. This role will define and implement fluidics automation (fill and packaging) systems and maintain/troubleshoot functional issues. This person will work to assess all reagent production operations for the implementation of semi-automated or automated systems that will support improved reagent production repeatability, quality and output.
This position will report to the Senior VP of Operations and is located in San Carlos, CA. The position requires a full-time onsite presence.

Responsibilities

• In partnership with Development, identify equipment, implement production processes that are scaled to support production capacity needs; transfer production and quality processes into all production environments (internal and external manufacturing); Create process documentation; Establish process operating parameters that yield consistent reagent quality
• Perform automated equipment programming (e.g. Hamilton fluidics dispensing equipment) on an ongoing basis to support new reagent formulations and changes to order delivery configurations
• Continually review production capacity for requirements and make recommendations for process and CAPEX upgrades that scale to meet production capacity requirements
• Utilize a systematic approach, such as designed experiments, to qualify new equipment and processes and set processing parameters
• Implement corrective actions and process improvements to resolve non-conformance issues
• Implement Statistical Process Control techniques and data monitoring to ensure that processes are operating in line with required parameters and capable of producing repeatable, high-quality reagents
• Develop production and capacity metrics and send out reporting on a regular basis
• Create and implement continuous improvement plans
• Provide feedback to cross-functional partners on manufacturability and scalability of all reagent SOP’s and protocols as they are developed
• Support the implementation of LIMS systems to ensure that process documentation, ongoing production lot monitoring, and other tracking requirements are identified and incorporated appropriately

Requirements

• Bachelor's Degree in Biological/Life Sciences, Chemistry, Molecular Biology, Biochemistry or related field, or equivalent combination of education and work-related experience
• A minimum of 8 years of industry experience related to the development, scaling, automation, and tech transfer of reagents
• Experience in setting up an automation line including the specification of fluidics/automated and semi-automated filling equipment scaled to meet budget and production volume requirements; ability to perform equipment programming to support production requirements
• Experience in working with equipment manufacturers to specify and ensure that purchased equipment meets the needs of the business and is installed to support schedule requirements
• Demonstrated ability to utilize statistical process control and experimental design techniques to evaluate and qualify reagent production equipment and processes
• Ability to assess, program, implement, manage, troubleshoot and maintain fluidics automation equipment and other production equipment
• Experience in developing quality improvement programs and metrics to monitor reagent production processes
• Experience in working with external manufacturing/CMO’s to implement and scale reagent production processes and quality management programs 
• Must be comfortable with being a “hands-on” contributor as well as able to assess production forecasts and new product development activities to ensure that production lines are appropriately equipped and scaled to meet ongoing production needs
• Ability to train production team members on new production processes and the use of associated equipment
• Demonstrate data-based decision making and analytical skills to troubleshoot and improve production processes
• Experience with implementing and utilizing a LIMS system
• Must be a team player and able to develop excellent cross functional relationships
• Must be a player-coach a